JMS WINGEATER A.V.FISTULA NEEDLE SET 820-5002-33Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 08888483005291), received between Aug 17, 2017 and Sep 19, 2019 — classified as 6 deaths, 21 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (9 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• InjurySep 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN AREA TECHNICAL OPERATIONS MANAGER (ATOM) REPORTED THAT A HEMODIALYSIS PATIENT EXPERIENCED HEMOLYSIS EVENT. UPON FOLLOW UP, THE HEMOLYSIS EVENT APPEARS TO HAVE OCCURRED BETWEEN (B)(6) 2019. THE PATIENT'S PRE-HEMODIALYSIS TREATMENT LABS WERE DRAWN ON (B)(6) 2019 WITHOUT ANY REPORTED ISSUES WITH THE LAB SPECIMEN. ON (B)(6) 2019, THE CLINIC MANAGER REVIEWED THE LAB RESULTS WHICH WERE DRAWN POST HEMODIALYSIS TREATMENT AND NOTICED THE PATIENT HAD A DROP IN THEIR BASELINE HEMOGLOBIN FROM 11 TO 9. 5. THE PATIENT REQUIRED A BLOOD TRANSFUSION; HOWEVER, THEY WERE NOT ADMITTED TO THE HOSPITAL. THE PATIENT WAS REPORTED DIALYZING WITH A FRESENIUS 2008T HEMODIALYSIS MACHINE, FRESENIUS BLOODLINES, FRESENIUS 180 DIALYZERS, FRESENIUS GRANUFLO ACID (2551) 2. 0 POTASSIUM/2. 5 CALCIUM, FRESENIUS NATURALYTE 4000 BICARBONATE, FRESENIUS CLIC BLOOD CHAMBER AND FRESENIUS NORMAL SALINE. IT WAS REPORTED THERE WERE NO VISUAL DEFECTS OR ANYTHING UNEXPECTED WITH ANY OF THE FRESENIUS PRODUCTS USED, AS WELL AS NO MACHINE ALARMS, CLOTTING EVENTS AND/OR DIALYZER LEAKS IN RELATION TO THE HEMOLYSIS EVENT. IT WAS REPORTED THERE WAS NOTHING UNUSUAL IN ANY OF THE HEMODIALYSIS TREATMENTS. THERE WERE NO VISIBLE SIGNS OF

  Patient problems: Hemolysis

  MAUDE report 9085658 ↗
• InjurySep 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN AREA TECHNICAL OPERATIONS MANAGER (ATOM) REPORTED THAT A HEMODIALYSIS PATIENT EXPERIENCED HEMOLYSIS EVENT. UPON FOLLOW UP, THE HEMOLYSIS EVENT APPEARS TO HAVE OCCURRED BETWEEN (B)(6) 2019. THE PATIENT'S PRE-HEMODIALYSIS TREATMENT LABS WERE DRAWN ON (B)(6) 2019 WITHOUT ANY REPORTED ISSUES WITH THE LAB SPECIMEN. ON (B)(6) 2019, THE CLINIC MANAGER REVIEWED THE LAB RESULTS WHICH WERE DRAWN POST HEMODIALYSIS TREATMENT AND NOTICED THE PATIENT HAD A DROP IN THEIR BASELINE HEMOGLOBIN FROM 9. 0 TO 6. 7. THE PATIENT REQUIRED A BLOOD TRANSFUSION ON (B)(6) 2019; HOWEVER, THEY WERE NOT ADMITTED TO THE HOSPITAL. THE PATIENT WAS REPORTED DIALYZING WITH A FRESENIUS 2008T HEMODIALYSIS MACHINE, FRESENIUS BLOODLINES, FRESENIUS 160 DIALYZERS, FRESENIUS GRANUFLO ACID (2551) 2. 0 POTASSIUM /2. 5 CALCIUM, FRESENIUS NATURALYTE 4000 BICARBONATE, FRESENIUS CLIC BLOOD CHAMBER AND FRESENIUS NORMAL SALINE. IT WAS REPORTED THERE WERE NO VISUAL DEFECTS OR ANYTHING UNEXPECTED WITH ANY OF THE FRESENIUS PRODUCTS USED, AS WELL AS NO MACHINE ALARMS, CLOTTING EVENTS AND/OR DIALYZER LEAKS IN RELATION TO THE HEMOLYSIS EVENT. IT WAS REPORTED THERE WAS NOTHING UNUSUAL IN ANY OF THE HEMODIALYSIS TREATMENTS. THERE WERE N

  Patient problems: Hemolysis

  MAUDE report 9085650 ↗
• InjurySep 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN AREA TECHNICAL OPERATIONS MANAGER (ATOM) REPORTED THAT A HEMODIALYSIS PATIENT EXPERIENCED HEMOLYSIS EVENT. UPON FOLLOW UP, THE HEMOLYSIS EVENT APPEARS TO HAVE OCCURRED BETWEEN (B)(6) 2019. THE PATIENT'S PRE-HEMODIALYSIS TREATMENT LABS WERE DRAWN ON (B)(6) 2019 WITHOUT ANY REPORTED ISSUES WITH THE LAB SPECIMEN. ON (B)(6) 2019, THE CLINIC MANAGER REVIEWED THE LAB RESULTS WHICH WERE DRAWN POST HEMODIALYSIS TREATMENT AND NOTICED THE PATIENT HAD A DROP IN THEIR BASELINE HEMOGLOBIN FROM 12 TO 9. 6. THE PATIENT WAS ADMITTED INTO THE HOSPITAL ON (B)(6) 2019 WITH A HEMOGLOBIN OF 7. 7 AND REQUIRED A BLOOD TRANSFUSION. FURTHER DETAILS REGARDING THE PATIENT'S HOSPITALIZATION ARE CURRENTLY UNKNOWN. REPORTEDLY, THE PATIENT CONTINUES TO RECEIVE HEMODIALYSIS TREATMENTS. THE PATIENT WAS REPORTED DIALYZING WITH A FRESENIUS 2008T HEMODIALYSIS MACHINE, FRESENIUS BLOODLINES, FRESENIUS DIALYZERS, FRESENIUS GRANUFLO ACID (2551) 2. 0 POTASSIUM/2. 5 CALCIUM, FRESENIUS NATURALYTE 4000 BICARBONATE, FRESENIUS CLIC BLOOD CHAMBER AND FRESENIUS NORMAL SALINE. IT WAS REPORTED THERE WERE NO VISUAL DEFECTS OR ANYTHING UNEXPECTED WITH ANY OF THE FRESENIUS PRODUCTS USED, AS WELL AS NO MACHINE ALARMS, CLOTTING EVEN

  Patient problems: Hemolysis

  MAUDE report 9085649 ↗
• InjurySep 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN AREA TECHNICAL OPERATIONS MANAGER (ATOM) REPORTED THAT A HEMODIALYSIS PATIENT EXPERIENCED HEMOLYSIS EVENT. UPON FOLLOW UP, THE HEMOLYSIS EVENT APPEARS TO HAVE OCCURRED BETWEEN (B)(6) 2019. THE PATIENT'S PRE-HEMODIALYSIS TREATMENT LABS WERE DRAWN ON (B)(6) 2019 WITHOUT ANY REPORTED ISSUES WITH THE LAB SPECIMEN. ON 06/19/2019, THE CLINIC MANAGER REVIEWED THE LAB RESULTS WHICH WERE DRAWN POST HEMODIALYSIS TREATMENT AND NOTICED THE PATIENT HAD A DROP IN THEIR BASELINE HEMOGLOBIN FROM 8. 9 TO 7. 2. THE PATIENT WAS ADMITTED INTO THE HOSPITAL DUE TO WEAKNESS ON (B)(6) 2019 WITH A HEMOGLOBIN OF 5. 9 AND POSITIVE SCHISTOCYTES. THE PATIENT REQUIRED A BLOOD TRANSFUSION. THE PATIENT WAS DISCHARGED ON (B)(6) 2019. FURTHER DETAILS REGARDING THE PATIENT'S HOSPITALIZATION ARE CURRENTLY UNKNOWN. REPORTEDLY, THE PATIENT CONTINUES TO RECEIVE HEMODIALYSIS TREATMENTS. THE PATIENT WAS REPORTED DIALYZING WITH A FRESENIUS 2008T HEMODIALYSIS MACHINE, FRESENIUS BLOODLINES, FRESENIUS 160 AND 180 DIALYZERS, FRESENIUS GRANUFLO ACID (2551) 2. 0 POTASSIUM/2. 5 CALCIUM, FRESENIUS NATURALYTE 4000 BICARBONATE, FRESENIUS CLIC BLOOD CHAMBER AND FRESENIUS NORMAL SALINE. IT WAS REPORTED THERE WERE NO VISUAL DEFECTS

  Patient problems: Hemolysis

  MAUDE report 9085645 ↗
• InjurySep 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN AREA TECHNICAL OPERATIONS MANAGER (ATOM) REPORTED THAT A HEMODIALYSIS PATIENT EXPERIENCED HEMOLYSIS EVENT. UPON FOLLOW UP, THE HEMOLYSIS EVENT APPEARS TO HAVE OCCURRED BETWEEN (B)(6) 2019 AND (B)(6) 2019. THE PATIENT'S PRE-HEMODIALYSIS TREATMENT LABS WERE DRAWN ON (B)(6) 2019 WITHOUT ANY REPORTED ISSUES WITH THE LAB SPECIMEN. ON (B)(6) 2019, THE CLINIC MANAGER REVIEWED THE LAB RESULTS WHICH WERE DRAWN POST HEMODIALYSIS TREATMENT AND NOTICED THE PATIENT HAD A DROP IN THEIR BASELINE HEMOGLOBIN FROM 12.5 TO 11. THE PATIENT WAS ADMITTED INTO THE HOSPITAL DUE TO WEAKNESS ON (B)(6) 2019 WITH A HEMOGLOBIN OF 8. 6 AND REQUIRED A BLOOD TRANSFUSION. THE PATIENT WAS DISCHARGED ON (B)(6) 2019. FURTHER DETAILS REGARDING THE PATIENT'S HOSPITALIZATION ARE CURRENTLY UNKNOWN. REPORTEDLY, THE PATIENT CONTINUES TO RECEIVE HEMODIALYSIS TREATMENTS. THE PATIENT WAS REPORTED DIALYZING WITH A FRESENIUS 2008T HEMODIALYSIS MACHINE, FRESENIUS BLOODLINES, FRESENIUS DIALYZERS, FRESENIUS GRANUFLO ACID (2551). 0 POTASSIUM/2. 5 CALCIUM, FRESENIUS NATURALYTE 4000 BICARBONATE, FRESENIUS CLIC BLOOD CHAMBER AND FRESENIUS NORMAL SALINE. IT WAS REPORTED THERE WERE NO VISUAL DEFECTS OR ANYTHING UNEXPECTED WITH ANY OF

  Patient problems: Hemolysis

  MAUDE report 9085644 ↗
• InjurySep 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN AREA TECHNICAL OPERATIONS MANAGER (ATOM) REPORTED THAT A HEMODIALYSIS PATIENT EXPERIENCED HEMOLYSIS EVENT. UPON FOLLOW UP, THE HEMOLYSIS EVENT APPEARS TO HAVE OCCURRED BETWEEN (B)(6) 2019. THE PATIENT'S PRE-HEMODIALYSIS TREATMENT LABS WERE DRAWN ON (B)(6) 2019 WITHOUT ANY REPORTED ISSUES WITH THE LAB SPECIMEN. ON 06/19/2019, THE CLINIC MANAGER REVIEWED THE LAB RESULTS WHICH WERE DRAWN POST HEMODIALYSIS TREATMENT AND NOTICED THE PATIENT HAD A DROP IN THEIR BASELINE HEMOGLOBIN FROM 8. 7 TO 8. 4. THE PATIENT WAS ADMITTED INTO THE HOSPITAL ON (B)(6) 2019 WITH COMPLAINTS OF WEAKNESS AND REQUIRED A BLOOD TRANSFUSION. THE PATIENT ALSO HAS A HISTORY OF UNSPECIFIED BLOOD DISORDER AND PREVIOUS BLOOD TRANSFUSION ON (B)(6) 2019. THE PATIENT WAS DISCHARGED ON (B)(6) 2019. FURTHER DETAILS REGARDING THE PATIENT'S HOSPITALIZATION ARE CURRENTLY UNKNOWN. REPORTEDLY, THE PATIENT CONTINUES TO RECEIVE HEMODIALYSIS TREATMENTS. THE PATIENT WAS REPORTED DIALYZING WITH A FRESENIUS 2008T HEMODIALYSIS MACHINE, FRESENIUS BLOODLINES, FRESENIUS DIALYZERS, FRESENIUS GRANUFLO ACID (2551) 2. 0 POTASSIUM/2. 5 CALCIUM, FRESENIUS NATURALYTE 4000 BICARBONATE, FRESENIUS CLIC BLOOD CHAMBER AND FRESENIUS NORMAL SALINE

  Patient problems: Hemolysis

  MAUDE report 9085641 ↗
• InjurySep 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN AREA TECHNICAL OPERATIONS MANAGER (ATOM) REPORTED THAT A HEMODIALYSIS PATIENT EXPERIENCED HEMOLYSIS EVENT. UPON FOLLOW UP, THE HEMOLYSIS EVENT APPEARS TO HAVE OCCURRED BETWEEN (B)(6) 2019 AND (B)(6) 2019. THE PATIENT'S PRE-HEMODIALYSIS TREATMENT LABS WERE DRAWN ON (B)(6) 2019 WITHOUT ANY REPORTED ISSUES WITH THE LAB SPECIMEN. ON (B)(6) 2019, THE CLINIC MANAGER REVIEWED THE LAB RESULTS WHICH WERE DRAWN POST HEMODIALYSIS TREATMENT AND NOTICED THE PATIENT HAD A DROP IN THEIR BASELINE HEMOGLOBIN FROM 10.5 TO 9. 3. THE PATIENT WAS ADMITTED INTO THE HOSPITAL ON (B)(6) 2019 AND REQUIRED A BLOOD TRANSFUSION. THE PATIENT WAS DISCHARGED ON (B)(6) 2019. FURTHER DETAILS REGARDING THE PATIENT'S HOSPITALIZATION ARE CURRENTLY UNKNOWN. REPORTEDLY, THE PATIENT CONTINUES TO RECEIVE HEMODIALYSIS TREATMENTS. THE PATIENT WAS REPORTED DIALYZING WITH A FRESENIUS 2008T HEMODIALYSIS MACHINE, FRESENIUS BLOODLINES, FRESENIUS DIALYZERS, FRESENIUS GRANUFLO ACID (2551) 2. 0 POTASSIUM/2. 5 CALCIUM, FRESENIUS NATURALYTE 4000 BICARBONATE, FRESENIUS CLIC BLOOD CHAMBER AND FRESENIUS NORMAL SALINE. IT WAS REPORTED THERE WERE NO VISUAL DEFECTS OR ANYTHING UNEXPECTED WITH ANY OF THE FRESENIUS PRODUCTS USED, AS WELL

  Patient problems: Hemolysis

  MAUDE report 9085633 ↗
• InjurySep 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN AREA TECHNICAL OPERATIONS MANAGER (ATOM) REPORTED THAT A HEMODIALYSIS PATIENT EXPERIENCED HEMOLYSIS EVENT. UPON FOLLOW UP, THE HEMOLYSIS EVENT APPEARS TO HAVE OCCURRED BETWEEN (B)(6) 2019 AND (B)(6) 2019. THE PATIENT'S PRE-HEMODIALYSIS TREATMENT LABS WERE DRAWN ON (B)(6) 2019 WITHOUT ANY REPORTED ISSUES WITH THE LAB SPECIMEN. ON (B)(6) 2019, THE CLINIC MANAGER REVIEWED THE LAB RESULTS WHICH WERE DRAWN POST HEMODIALYSIS TREATMENT AND NOTICED THE PATIENT HAD A DROP IN THEIR BASELINE HEMOGLOBIN FROM 11 TO 9.5. THE PATIENT REQUIRED A BLOOD TRANSFUSION; HOWEVER, THEY WERE NOT ADMITTED TO THE HOSPITAL. THE PATIENT WAS REPORTED DIALYZING WITH A FRESENIUS 2008T HEMODIALYSIS MACHINE, FRESENIUS BLOODLINES, FRESENIUS 180 DIALYZERS, FRESENIUS GRANUFLO ACID (2551) 2.0 POTASSIUM/2.5 CALCIUM, FRESENIUS NATURALYTE 4000 BICARBONATE, FRESENIUS CLIC BLOOD CHAMBER AND FRESENIUS NORMAL SALINE. IT WAS REPORTED THERE WERE NO VISUAL DEFECTS OR ANYTHING UNEXPECTED WITH ANY OF THE FRESENIUS PRODUCTS USED, AS WELL AS NO MACHINE ALARMS, CLOTTING EVENTS AND/OR DIALYZER LEAKS IN RELATION TO THE HEMOLYSIS EVENT. IT WAS REPORTED THERE WAS NOTHING UNUSUAL IN ANY OF THE HEMODIALYSIS TREATMENTS. THERE WERE NO VIS

  Patient problems: Hemolysis

  MAUDE report 9056903 ↗
• InjurySep 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN AREA TECHNICAL OPERATIONS MANAGER (ATOM) REPORTED THAT A HEMODIALYSIS PATIENT EXPERIENCED HEMOLYSIS EVENT. UPON FOLLOW UP, THE HEMOLYSIS EVENT APPEARS TO HAVE OCCURRED BETWEEN (B)(6) 2019 AND (B)(6) 2019. THE PATIENT'S PRE-HEMODIALYSIS TREATMENT LABS WERE DRAWN ON (B)(6) 2019 WITHOUT ANY REPORTED ISSUES WITH THE LAB SPECIMEN. ON (B)(6) 2019, THE CLINIC MANAGER REVIEWED THE LAB RESULTS WHICH WERE DRAWN POST HEMODIALYSIS TREATMENT AND NOTICED THE PATIENT HAD A DROP IN THEIR BASELINE HEMOGLOBIN FROM 9.0 TO 6.7. THE PATIENT REQUIRED A BLOOD TRANSFUSION ON (B)(6) 2019; HOWEVER, THEY WERE NOT ADMITTED TO THE HOSPITAL. THE PATIENT WAS REPORTED DIALYZING WITH A FRESENIUS 2008T HEMODIALYSIS MACHINE, FRESENIUS BLOODLINES, FRESENIUS 160 DIALYZERS, FRESENIUS GRANUFLO ACID (2551) 2.0 POTASSIUM/2.5 CALCIUM, FRESENIUS NATURALYTE 4000 BICARBONATE, FRESENIUS CLIC BLOOD CHAMBER AND FRESENIUS NORMAL SALINE. IT WAS REPORTED THERE WERE NO VISUAL DEFECTS OR ANYTHING UNEXPECTED WITH ANY OF THE FRESENIUS PRODUCTS USED, AS WELL AS NO MACHINE ALARMS, CLOTTING EVENTS AND/OR DIALYZER LEAKS IN RELATION TO THE HEMOLYSIS EVENT. IT WAS REPORTED THERE WAS NOTHING UNUSUAL IN ANY OF THE HEMODIALYSIS TREATMENTS. T

  Patient problems: Hemolysis

  MAUDE report 9050420 ↗
• InjurySep 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN AREA TECHNICAL OPERATIONS MANAGER (ATOM) REPORTED THAT A HEMODIALYSIS PATIENT EXPERIENCED HEMOLYSIS EVENT. UPON FOLLOW UP, THE HEMOLYSIS EVENT APPEARS TO HAVE OCCURRED BETWEEN (B)(6) 2019. THE PATIENT'S PRE-HEMODIALYSIS TREATMENT LABS WERE DRAWN ON (B)(6) 2019 WITHOUT ANY REPORTED ISSUES WITH THE LAB SPECIMEN. ON (B)(6) 2019, THE CLINIC MANAGER REVIEWED THE LAB RESULTS WHICH WERE DRAWN POST HEMODIALYSIS TREATMENT AND NOTICED THE PATIENT HAD A DROP IN THEIR BASELINE HEMOGLOBIN FROM 12.5 TO 11.1. THE PATIENT WAS ADMITTED INTO THE HOSPITAL DUE TO WEAKNESS ON (B)(6) 2019 WITH A HEMOGLOBIN OF 8.6 AND REQUIRED A BLOOD TRANSFUSION. THE PATIENT WAS DISCHARGED ON (B)(6) 2019. FURTHER DETAILS REGARDING THE PATIENT'S HOSPITALIZATION ARE CURRENTLY UNKNOWN. REPORTEDLY, THE PATIENT CONTINUES TO RECEIVE HEMODIALYSIS TREATMENTS. THE PATIENT WAS REPORTED DIALYZING WITH A FRESENIUS 2008T HEMODIALYSIS MACHINE, FRESENIUS BLOODLINES, FRESENIUS DIALYZERS, FRESENIUS GRANUFLO ACID (2551) 2.0 POTASSIUM/2.5 CALCIUM, FRESENIUS NATURALYTE 4000 BICARBONATE, FRESENIUS CLIC BLOOD CHAMBER AND FRESENIUS NORMAL SALINE. IT WAS REPORTED THERE WERE NO VISUAL DEFECTS OR ANYTHING UNEXPECTED WITH ANY OF THE FRESENIUS

  Patient problems: Hemolysis

  MAUDE report 9050345 ↗
• InjurySep 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN AREA TECHNICAL OPERATIONS MANAGER (ATOM) REPORTED THAT A HEMODIALYSIS PATIENT EXPERIENCED HEMOLYSIS EVENT. UPON FOLLOW UP, THE HEMOLYSIS EVENT APPEARS TO HAVE OCCURRED BETWEEN (B)(6) 2019. THE PATIENT'S PRE-HEMODIALYSIS TREATMENT LABS WERE DRAWN ON (B)(6) 2019 WITHOUT ANY REPORTED ISSUES WITH THE LAB SPECIMEN. ON (B)(6) 2019, THE CLINIC MANAGER REVIEWED THE LAB RESULTS WHICH WERE DRAWN POST HEMODIALYSIS TREATMENT AND NOTICED THE PATIENT HAD A DROP IN THEIR BASELINE HEMOGLOBIN FROM 12 TO 9. 6. THE PATIENT WAS ADMITTED INTO THE HOSPITAL ON (B)(6) 2019 WITH A HEMOGLOBIN OF 7. 7 AND REQUIRED A BLOOD TRANSFUSION. FURTHER DETAILS REGARDING THE PATIENT'S HOSPITALIZATION AND DISCHARGE DATE ARE CURRENTLY UNKNOWN. REPORTEDLY, THE PATIENT CONTINUES TO RECEIVE HEMODIALYSIS TREATMENTS. THE PATIENT WAS REPORTED DIALYZING WITH A FRESENIUS 2008T HEMODIALYSIS MACHINE, FRESENIUS BLOODLINES, FRESENIUS DIALYZERS, FRESENIUS GRANUFLO ACID (2551) 2.0 POTASSIUM/2.5 CALCIUM, FRESENIUS NATURALYTE 4000 BICARBONATE, FRESENIUS CLIC BLOOD CHAMBER AND FRESENIUS NORMAL SALINE. IT WAS REPORTED THERE WERE NO VISUAL DEFECTS OR ANYTHING UNEXPECTED WITH ANY OF THE FRESENIUS PRODUCTS USED, AS WELL AS NO MACHINE ALAR

  Patient problems: Hemolysis

  MAUDE report 9047520 ↗
• InjurySep 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN AREA TECHNICAL OPERATIONS MANAGER (ATOM) REPORTED THAT A HEMODIALYSIS PATIENT EXPERIENCED HEMOLYSIS EVENT. UPON FOLLOW UP, THE HEMOLYSIS EVENT APPEARS TO HAVE OCCURRED BETWEEN (B)(6) 2019. THE PATIENT'S PRE-HEMODIALYSIS TREATMENT LABS WERE DRAWN ON (B)(6) 2019 WITHOUT ANY REPORTED ISSUES WITH THE LAB SPECIMEN. ON (B)(6) 2019, THE CLINIC MANAGER REVIEWED THE LAB RESULTS WHICH WERE DRAWN POST HEMODIALYSIS TREATMENT AND NOTICED THE PATIENT HAD A DROP IN THEIR BASELINE HEMOGLOBIN FROM 8.9 TO 7.2. THE PATIENT WAS ADMITTED INTO THE HOSPITAL DUE TO WEAKNESS ON (B)(6) 2019 WITH A HEMOGLOBIN OF 5.9 AND POSITIVE SCHISTOCYTES. THE PATIENT REQUIRED A BLOOD TRANSFUSION. THE PATIENT WAS DISCHARGED ON (B)(6) 2019. FURTHER DETAILS REGARDING THE PATIENT'S HOSPITALIZATION ARE CURRENTLY UNKNOWN. REPORTEDLY, THE PATIENT CONTINUES TO RECEIVE HEMODIALYSIS TREATMENTS. THE PATIENT WAS REPORTED DIALYZING WITH A FRESENIUS 2008T HEMODIALYSIS MACHINE, FRESENIUS BLOODLINES, FRESENIUS 160 AND 180 DIALYZERS, FRESENIUS GRANUFLO ACID (2551) 2.0 POTASSIUM/2. 5 CALCIUM, FRESENIUS NATURALYTE 4000 BICARBONATE, FRESENIUS CLIC BLOOD CHAMBER AND FRESENIUS NORMAL SALINE. IT WAS REPORTED THERE WERE NO VISUAL DEFECTS OR

  Patient problems: Hemolysis

  MAUDE report 9014463 ↗
• InjurySep 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN AREA TECHNICAL OPERATIONS MANAGER (ATOM) REPORTED THAT A HEMODIALYSIS PATIENT EXPERIENCED HEMOLYSIS EVENT. UPON FOLLOW UP, THE HEMOLYSIS EVENT APPEARS TO HAVE OCCURRED BETWEEN (B)(6) 2019 AND (B)(6) 2019. THE PATIENT'S PRE-HEMODIALYSIS TREATMENT LABS WERE DRAWN ON (B)(6) 2019 WITHOUT ANY REPORTED ISSUES WITH THE LAB/ SPECIMEN. ON (B)(6) 2019, THE CLINIC MANAGER REVIEWED THE LAB RESULTS WHICH WERE DRAWN POST HEMODIALYSIS TREATMENT AND NOTICED THE PATIENT HAD A DROP IN THEIR BASELINE HEMOGLOBIN FROM 8. 7 TO 8. 4. THE PATIENT WAS ADMITTED INTO THE HOSPITAL ON (B)(6) 2019 WITH COMPLAINTS OF WEAKNESS AND REQUIRED A BLOOD TRANSFUSION. THE PATIENT ALSO HAS A HISTORY OF UNSPECIFIED BLOOD DISORDER AND PREVIOUS BLOOD TRANSFUSION ON (B)(6) 2019. THE PATIENT WAS DISCHARGED ON (B)(6) 2019. FURTHER DETAILS REGARDING THE PATIENT'S HOSPITALIZATION ARE CURRENTLY UNKNOWN. REPORTEDLY, THE PATIENT CONTINUES TO RECEIVE HEMODIALYSIS TREATMENTS. THE PATIENT WAS REPORTED DIALYZING WITH A FRESENIUS 2008T HEMODIALYSIS MACHINE, FRESENIUS BLOODLINES, FRESENIUS DIALYZERS, FRESENIUS GRANUFLO ACID (2551) 2. 0 POTASSIUM/2. 5 CALCIUM, FRESENIUS NATURALYTE 4000 BICARBONATE, FRESENIUS CLIC BLOOD CHAMBER AND FRESE

  Patient problems: Hemolysis

  MAUDE report 9013944 ↗
• InjurySep 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN AREA TECHNICAL OPERATIONS MANAGER (ATOM) REPORTED THAT A HEMODIALYSIS PATIENT EXPERIENCED HEMOLYSIS EVENT. UPON FOLLOW UP, THE HEMOLYSIS EVENT APPEARS TO HAVE OCCURRED BETWEEN (B)(6) 2019. THE PATIENT'S PRE-HEMODIALYSIS TREATMENT LABS WERE DRAWN ON (B)(6) 2019 WITHOUT ANY REPORTED ISSUES WITH THE LAB SPECIMEN. ON 06/19/2019, THE CLINIC MANAGER REVIEWED THE LAB RESULTS WHICH WERE DRAWN POST HEMODIALYSIS TREATMENT AND NOTICED THE PATIENT HAD A DROP IN THEIR BASELINE HEMOGLOBIN FROM 10.5 TO 9.3. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2019 AND REQUIRED A BLOOD TRANSFUSION. THE PATIENT WAS DISCHARGED (B)(6) 2019. FURTHER DETAILS REGARDING THE PATIENT'S HOSPITALIZATION ARE CURRENTLY UNKNOWN. REPORTEDLY, THE PATIENT CONTINUES TO RECEIVE HEMODIALYSIS TREATMENTS. IT WAS REPORTED THERE WAS NOTHING UNUSUAL IN ANY OF THE HEMODIALYSIS TREATMENTS. THIS WAS BROUGHT TO OUR ATTENTION ON 08/19/2019 AND AS OF (B)(6) 2019 NO CAUSE OF HEMOLYSIS WAS DETERMINED.

  Patient problems: Hemolysis

  MAUDE report 9013894 ↗
• InjuryJan 23, 2019Device Slipped; Device Dislodged or Dislocated; Expulsion; Device Slipped; Device Dislodged or Dislocated; Expulsion

  ON (B)(6) 2018, A HEMODIALYSIS PATIENT, ARRIVED TO TREATMENT ALERT AND ORIENTATED. PRE-DIALYSIS VITAL SIGNS OBTAINED: B/P: 152/77; PULSE 73; RESP 20; TEMP: 97.6. TREATMENT WAS INITIATED AT 13:21, AND VS CHECKED EVERY 20 MINUTES. AT 14:01, B/P WAS 128/68; PULSE 75. APPROXIMATELY 8 MINUTES LATER, THE MACHINE ALARMED. THE PATIENT WAS FOUND UNRESPONSIVE WITH THE TIP OF THE VENOUS NEEDLE DISLODGED. TAPE WAS STILL INTACT ON THE PATIENT'S SKIN. LARGE AMOUNTS OF BLOOD WERE NOTED ON THE FLOOR. EBL 300-400 ML. THE VENOUS LINE WAS CLAMPED AND PRESSURE APPLIED TO THE VENOUS CANNULATION SITE. BLOOD WAS RETURNED VIA THE ARTERIAL NEEDLE, AND NORMAL SALINE WAS ADMINISTERED VIA THE ARTERIAL NEEDLE; APPROXIMATELY 800 ML NORMAL SALINE WAS ADMINISTERED. OXYGEN WAS APPLIED VIA MASK AT 3 LPM; AED PADS PLACED ON CHEST; CPR INITIATED. 911 WAS CALLED. THE PATIENT STARTED SPONTANEOUSLY BREATHING AT 14:13. VS UPON DISCHARGE FROM FACILITY: B/P 156/99; PULSE 102; RESP 23; TEMP 97.8. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL VIA EMS AND ADMITTED. PATIENT WAS TRANSFUSED WITH 3 UNITS OF PACKED RED BLOOD CELLS (PRBCS) DURING HOSPITALIZATION AND WAS DISCHARGED ON (B)(6) 2019, RETURNING TO THE FACILITY FOR HEMODIA

  Patient problems: Blood Loss; Cardiopulmonary Arrest; Hypovolemia

  MAUDE report 8269836 ↗
• InjuryDec 19, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  A HEMODIALYSIS PATIENT SCHEDULED 3.75 HOUR HEMODIALYSIS TREATMENT WAS INITIATED AT 11:40AM. B/P 122/73, PULSE 92. AT 12:26, B/P WAS 103/43, PULSE 89; 300 ML NORMAL SALINE WAS ADMINISTERED. NORMAL SALINE WAS ADMINISTERED OVER THE NEXT 2 HOURS FOR HYPOTENSION, TOTALING 1700ML. WHEN DISCONTINUING TREATMENT AT 14:32, THE PCT PICKED UP THE VENOUS BLOODLINE AND NOTED IT WAS NOT SECURELY TIGHTENED TO THE FISTULA NEEDLE AND WAS LEAKING BLOOD. THE PCT TIGHTENED THE CONNECTION TO ADMINISTERED NORMAL SALINE AND CONTINUE TO RETURN THE BLOOD. BLOOD WAS NOTED ON THE FLOOR; NO BLOOD WAS NOTED ON THE FRONT OF THE PATIENT, CHAIR, OR CHAIRSIDE TABLE. IT APPEARED BLOOD WAS DRIPPING ON THE OUTSIDE OF HIS ARM TO THE FLOOR. 600ML NORMAL SALINE WAS ADMINISTERED. PATIENT DID NOT LOSE CONSCIOUSNESS AT ANY TIME. EMS WAS CALLED AND THE PATIENT WAS TRANSPORTED TO THE HOSPITAL AND ADMITTED. UPON DISCHARGE THE DIALYSIS FACILITY, THE PATIENT WAS AWAKE AND ALERT, AND B/P WAS 114/48; PULSE 89; RESP 17; TEMP 97.5. PATIENT RECEIVED 3 UNITS OF PACKED RED BLOOD CELLS (PRBCS) DURING THE HOSPITALIZATION. HE WAS DISCHARGED FROM THE HOSPITAL (B)(6) 2018, RETURNING FOR HEMODIALYSIS ON (B)(6) 2018.

  Patient problems: Dizziness; Exsanguination; Hypovolemia

  MAUDE report 8182752 ↗
• InjuryDec 7, 2018Device Dislodged or Dislocated; Expulsion; Device Dislodged or Dislocated; Expulsion

  ON (B)(6) 2018, A HEMODIALYSIS PATIENT, APPROXIMATELY 2.5 HOURS IN A SCHEDULED 4 HOUR HEMODIALYSIS TREATMENT WHEN THE DIALYSIS MACHINE ALARMED. THE PATIENT WAS FOUND IN THE HEMODIALYSIS CHAIR WITH HER EYES CLOSED AND VENOUS FISTULA NEEDLE WAS NOTED BE TO BE DISLODGED WITH THE TAPE INTACT. BLOOD WAS PUMPING OUT OF THE VENOUS NEEDLE; A POOL OF BLOOD WAS NOTED UNDER THE CHAIR APPROXIMATELY THE SIZE OF THE CHAIR. THE BLOOD PUMP WAS STOPPED IMMEDIATELY, AND NORMAL SALINE WAS ADMINISTERED VIA THE ARTERIAL FISTULA NEEDLE. APPROXIMATELY 400ML NORMAL SALINE BOLUS, THE PATIENT OPENED HER EYES TO VERBAL INSTRUCTION. 911 WERE CALLED. A TOTAL OF 1.4 LITER OF NORMAL SALINE WAS ADMINISTERED. EMS WITH A B/P OF 126/961 WAS DISCHARGED ON PATIENT. UPON ADMISSION TO EMERGENCY ROOM, HER SYSTOLIC BLOOD PRESSURE WAS IN THE 70'S AND SHE WAS BRADYCARDIC. 1 LITER OF FLUID AND 2 UNITS PACKED RED BLOOD CELLS (PRBC) WAS INFUSED ON THE PATIENT. SHE WAS ADMITTED TO THE ICU FOR HEMORRHAGIC SHOCK AND DISCHARGED FROM THE HOSPITAL ON (B)(6) 2018, RETURNING FOR HERE NEXT SCHEDULED IN-CENTER HEMODIALYSIS TREATMENT ON (B)(6) 2018.

  Patient problems: Blood Loss; Hypovolemia; Loss of consciousness

  MAUDE report 8140758 ↗
• InjuryDec 7, 2018Device Dislodged or Dislocated; Expulsion; Device Dislodged or Dislocated; Expulsion

  ON (B)(6) 2018, A HEMODIALYSIS PATIENT, APPROXIMATELY 45 MINUTES INTO A SCHEDULED 4 HOUR HEMODIALYSIS TREATMENT WHEN THE DIALYSIS MACHINE ALARMED ARTERIAL PRESSURE. THE PATIENT WAS FOUND IN THE HEMODIALYSIS CHAIR WITH VENOUS FISTULA NEEDLE DISLODGED WITH THE TAPE INTACT ON WINGS OF THE VENOUS FISTULA NEEDLE. A POOL OF BLOOD WAS NOTED BELOW THE CHAIR, WHICH CONTINUED TO THE WALL BEHIND THE CHAIR. CHAIR WAS IN SEMI-RECLINED POSITION. EBL 300 ML. PATIENT WAS UNRESPONSIVE WITH ERRATIC RESPIRATORY RATE. BLOOD PRESSURE WAS 112/60, PULSE 60. 2 LITERS OF NORMAL SALINE WAS ADMINISTERED THROUGH ARTERIAL NEEDLE. PATIENT WAS PLACED IN TRENDELENBURG POSITION AND OXYGEN OF 10 L WAS APPLIED VIA NASAL CANNULA. PATIENT WAS DROWSY BUT RESPONDING TO VERBAL STIMULI. EMS WAS CALLED. ONE UNIT OF PACKED RED BLOOD CELLS (PRBC) WAS ADMINISTERED IN THE ER AND PATIENT WAS THEN DISCHARGED HOME. THE PATIENT RETURNED TO THE FACILITY FOR HIS NEXT SCHEDULED HEMODIALYSIS APPOINTMENT TREATMENT ON (B)(6) 2018.

  Patient problems: Blood Loss; Exsanguination; Loss of consciousness

  MAUDE report 8140757 ↗
• DeathOct 16, 2018Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, A HEMODIALYSIS PATIENT WAS GOING THROUGH A 3.5 HOUR HEMODIALYSIS TREATMENT WHEN THE PATIENT'S ARM WAS NOTED TO HAVE DROPPED ONTO CHAIR, CAUSING TENSION ON VENOUS LINE. THE VENOUS FISTULA NEEDLE WAS NOTED TO BE DISLODGED. PRESSURE WAS HELD TO VENOUS SITE; BLOOD WAS NORMAL AND NORMAL SALINE WAS ADMINISTERED VIA THE ARTERIAL FISTULA NEEDLE. OXYGEN WAS APPLIED VIA NASAL CANNULA, 911 WAS CALLED. PATIENT DID NOT AROUSE WITH PAINFUL STIMULI; CPR WAS INITIATED WITH ONE ROUND ADMINISTERED. APPROXIMATELY 800ML OF NORMAL SALINE ADMINISTERED. HEMOSTASIS ACHIEVED ON VENOUS CANNULATION SITE. THE PATIENT WAS THEN TRANSPORTED TO ER VIA EMS AND WAS TRANSFUSED WITH 2 UNITS PACKED RED BLOOD CELLS. UPON INSPECTION OF VENOUS NEEDLE, TAPE AND GAUZE DRESSING WERE STILL INTACT ON THE FISTULA NEEDLE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2018 BUT SUSTAINED A CARDIOPULMONARY ARREST IN HER HOME ON (B)(6) 2018 WHICH RESULTED IN HER DEATH.

  Patient problems: Cardiopulmonary Arrest; Hemorrhage/Blood Loss/Bleeding; Hypovolemia

  MAUDE report 7968307 ↗
• DeathOct 3, 2018Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, A HEMODIALYSIS PATIENT WAS GOING THROUGH A 3 HOUR HEMODIALYSIS TREATMENT THAT INVOLVED VENOUS NEEDLE DISLODGEMENT, HOSPITALIZATION AND DEATH. TWO (2) HOURS INTO THE SCHEDULED TREATMENT, PATIENT WAS FOUND TO BE UNRESPONSIVE. PRESSURE WAS HELD TO CANNULATION SITE, AND NORMAL SALINE ADMINISTERED VIA ARTERIAL LINE. APPROXIMATELY 1.5L OF BLOOD LOSS. 911 WERE CALLED, CPR WAS INITIATED AND AED APPLIED WHICH ADVISED NO SHOCK. A TOTAL OF 3 LITERS OF NORMAL SALINE WAS ADMINISTERED DURING RESUSCITATION. THE PATIENT WAS THEN TRANSPORTED TO THE HOSPITAL VIA EMS, WHERE THE PATIENT DIED. UPON INSPECTION OF THE VENOUS NEEDLE, IT WAS NOTED THAT TAPE AND GAUZE DRESSING WERE STILL INTACT ON THE FISTULA NEEDLE. THE MACHINE WAS SEQUESTERED AND FUNCTIONAL TEST WAS PERFORMED. ALL REQUIRED PARAMETERS PASSED.

  Patient problems: Cardiopulmonary Arrest; Hemorrhage/Blood Loss/Bleeding; Hypovolemia

  MAUDE report 7968150 ↗
• DeathMar 4, 2018Adverse Event Without Identified Device or Use Problem

  WITH REFERENCE TO (B)(6) FDA LETTER.PDF, ON (B)(6) 2018, A HEMODIALYSIS (HD) PATIENT COMPLETED A SCHEDULED HD TREATMENT WITHOUT ANY ISSUES BUT WAS LATER FOUND BLEEDING IN HER CAR AND SUBSEQUENTLY EXPIRED. FOLLOW-UP INFORMATION OBTAINED VIA PHONE CALL WITH THE CLINIC MANAGER THAT THE PATIENT HAD NO ISSUES DURING OR AFTER TREATMENT. THERE WERE NO ALLEGATIONS OF ANY HD DEVICE OR PRODUCT MALFUNCTION. THE PATIENT WAS DISCHARGED TO HOME FOLLOWING TREATMENT, WHERE SHE DRIVES TO THE CLINIC BY HERSELF. THE PATIENT LEFT THE CLINIC AROUND 1015 WITHOUT ANY KNOWN ISSUE WITH HER FISTULA. IT WAS UNKNOWN WHAT THE PATIENT HAD DONE AFTER SHE LEFT THE CLINIC. IT WAS VERY COLD OUTSIDE THAT DAY AND THE PATIENT WAS WEARING A HEAVY JACKET. AT SOME TIME WHILE DRIVING OUT HER CAR AFTER TREATMENT, THE PATIENT NOTICED BLOOD LEAKING FROM HER FISTULA AND PULLED OVER AND STOPPED TO CALL EMS. THE SOURCE OF BLOOD LOSS WAS FROM HER AV FISTULA (RIGHT UPPER/BRACHIAL BASILIC). EMERGENCY TEAM FOUND HER AND TOOK HER TO THE HOSPITAL BUT SHE EXPIRED THAT DAY. IT WAS NOT KNOWN WHETHER PATIENT EXPIRED IN HER CAR OR WHILE IN ROUTE OR WHILE IN HOSPITAL. IT WAS REPORTED IN THE FACILITY'S ADVERSE EVENT FORM THAT THERE WAS POOR

  Patient problems: Blood Loss; Death

  MAUDE report 7312367 ↗
• DeathFeb 13, 2018Migration or Expulsion of Device; Device Dislodged or Dislocated; Unintended Movement; Migration or Expulsion of Device; Device Dislodged or Dislocated; Unintended Movement

  DATED 11 JAN 2018, JMS(B)(4) HAD RECEIVED A MEDWATCH DOCUMENT (B)(4) FROM OUT-PATIENT DIALYSIS FACILITY WHICH REPORTS ADVERSE EVENT/DEATH FROM BLOOD LOSS ASSOCIATED WITH VENOUS AND ARTERIAL NEEDLE DISLODGMENT. HEMODIALYSIS PATIENT WAS SCHEDULED FOR REGULAR DIALYSIS TREATMENT. HEMODIALYSIS WAS INITIATED VIA LEFT UPPER AVG UTILIZING 2 # 15 GAUGE WINGEATER NEEDLES. TREATMENT WAS INITIATED AT APPROXIMATELY 1309 FOR A 4 HOUR TREATMENT. AT APPROXIMATELY 1435, PATIENT'S BP WAS 150/71 AND PULSE 80. AT APPROXIMATELY 1510, PATIENT APPEARED TO BE IN DISTRESS AND WAS PLACED IN TRENDELENBERG POSITION, WHERE BLOOD WAS NOTED UNDER HER CHAIR. THERE WAS NO REPORTED AUDIBLE MACHINE ALARM. THE INCIDENT WAS DISCOVERED DURING THE SECOND HOUR FROM SCHEDULED 4 HOUR TREATMENT. STAFFS AT THE DIALYSIS CENTER WERE UNCERTAIN OF WHY THERE WAS NO ALARM SOUNDED FROM THE FRESENIUS T. MACHINE. STAFFS WERE USING FRESENIUS COMBISET BLOODLINES. THE MANAGER HAD STATED THAT THE ESTIMATED BLOOD LOSS ON THE FLOOR WAS APPROXIMATELY 1300CC. ADDITIONAL BLOOD WAS NOTED ON PATIENT'S CLOTHING. PATIENT WAS IN REHABILITATION TO TRY AND RECOVER FROM A RECENT CEREBROVASCULAR ACCIDENT (CVA), WHERE SHE WAS LEFT WITH LEFT SIDED WEAKN

  Patient problems: Blood Loss; Cardiac Arrest; Exsanguination

  MAUDE report 7269115 ↗
• DeathJan 10, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DATED 05 DEC 17, JMS (B)(4) HAD RECEIVED A MEDWATCH DOCUMENT (#(B)(4)) FROM (B)(6) REGARDING THIS INCIDENT. THE OUTPATIENT DIALYSIS FACILITY NOTIFIED US OF BLOOD LOSS OF 200ML DUE TO DISLODGE AT BOTH ARTERIAL AND VENOUS NEEDLES. PATIENT HAD A HISTORY OF STROKE WITH LEFT SIDE WEAKNESS. SHE WAS USING HER RIGHT FOREARM DURING TREATMENT. THE CLINIC MANAGER STATED THAT THERE WAS NO ABNORMALITY NOTED WITH THE WINGEATER SET BEFORE INSERTION OR AFTER THEY WERE FOUND DISLODGED. THERE WERE NO ABNORMALITIES DURING THE FIRST 3.75 HOURS OF TREATMENT. THE PATIENT WAS NOT REPORTED TO BE ANXIOUS OR RESTLESS. THE MANAGER STATED THAT THE PATIENT WOULD OFTEN SAY SHE WANTED TO GO HOME NEAR THE END OF HER TREATMENT. IN 3.75 HOURS INTO SCHEDULED 4 HOUR HEMODIALYSIS TREATMENT, MACHINE WAS ALARMING AND PATIENT WAS FOUND VOMITING AND UNCONSCIOUS. PATIENT'S B/P WAS 57/37 AND PULSE 65. FOR THE CAUSE OF ALARM DURING THE EVENT, THE MANAGER BELIEVES IT WAS THE ARTERIAL MACHINE ALARM THAT WENT OFF WHICH WILL OCCUR WHEN THE MACHINE SENSES THE DROP IN PRESSURE FROM THE NEEDLES COMING OUT FROM PATIENT'S ACCESS. THE PATIENT DID NOT COMPLETE THE TREATMENT. SHE WAS GIVEN A 400ML BOLUS OF NORMAL SALINE TO GET HER BLOOD

  Patient problems: Blood Loss; Death; Low Blood Pressure/ Hypotension

  MAUDE report 7177722 ↗
• InjuryNov 14, 2017Unintended Ejection; Device Dislodged or Dislocated; Unintended Ejection; Device Dislodged or Dislocated

  DATED (B)(6) 2017, JMSS HAD RECEIVED A MEDWATCH DOCUMENT (#(B)(4)) FROM (B)(6) REGARDING THIS INCIDENT. THE INITIAL REPORTER HAD CONFIRMED THAT THERE WAS NO OBVIOUS OR PRODUCT PROBLEM WITH JMS WINGEATER USED. THE INITIAL REPORTER'S INTERNAL INVESTIGATION INTO SUSPECT CAUSE WAS EITHER PATIENT MOVEMENT OR UNKNOWN MACHINE PARAMETERS SUCH AS SETTINGS. HE HAS RULED OUT TECHNICIAN ERROR AS ALL POLICIES AND PROCEDURES WERE FOLLOWED. PATIENT'S FISTULA ON UPPER RIGHT ARM ABOVE ELBOW. CERTIFIED CLINICAL HEMODIALYSIS TECHNICIAN (CCHT) WAS APPROACHING PATIENT TO PERFORM A 30 MINUTE VITAL SIGN CHECK 2 HOURS INTO A SCHEDULED 4 HOUR INCENTER HEMODIALYSIS TREATMENT AND THE FRESENIUS 2008K MACHINE STARTED ALARMING. PATIENT WAS FOUND UNRESPONSIVE TO VERBAL AND PAINFUL STIMULI AND BLOOD WAS NOTED ON FLOOR UNDER PATIENT'S CHAIR. THE ESTIMATED BLOOD LOSS WAS NOTED TO BE MORE THAN 300ML. PATIENT WAS PLACED IN TRENDELENBURG POSITION. VENOUS NEEDLE WAS NOTED TO BE DISLODGED. B/P WAS 83/40 AND PULSE 67. THE TECHNICIAN WHO DID VENIPUNCTURE FOLLOWED TAPING POLICY WITH 3 PIECES OF TAPE IN CHEVRON-STYLE. A DIFFERENT TECHNICIAN WHO DID THE 30 MINUTE VITAL SIGN CHECK SAW THAT 1 PIECE OF TAPE WAS INTACT ON TUBING

  Patient problems: Hypovolemia; Loss of consciousness; Low Blood Pressure/ Hypotension

  MAUDE report 7027144 ↗
• InjurySep 29, 2017Disconnection; Disconnection

  DURING HEMODIALYSIS (HD) TREATMENT, A PATIENT (B)(6) REPORTEDLY LOST APPROXIMATELY 800 TO 1000 MILLILITERS (ML) OF BLOOD AFTER THE VENOUS NEEDLE BECAME DISCONNECTED FROM THE BLOODLINES. THE CONNECTION WAS BETWEEN THE LUER CONNECTOR OF JMS AVF NEEDLE AND BLOODLINE. THE CONNECTORS WERE ATTACHED TO EACH OTHER AND SCREWED INTO PLACE. THERE WAS NO TAPING AT LUER CONNECTOR TO BLOODLINES AND NO LUBRICANT OR DISINFECTANT WAS USED AT THE CONNECTING PORTION. THE STAFF DID NOT OBSERVED ANY ABNORMALITIES DURING/ AFTER CONNECTION FITTING OR DURING PERIODIC CHECK. THE DISCONNECTION INCIDENT OCCURRED AROUND 2 HOURS AND 45MINS INTO THE HEMODIALYSIS TREATMENT. THE TOTAL DURATION FOR PATIENT TOOK 4 HOURS TO COMPLETE HIS HEMODIALYSIS TREATMENT. THE STAFF SAW THE BLOOD LEAKAGE AND MOVED TO ACTION. HOWEVER, THE STAFF WAS UNSURE WHETHER THE DISCONNECTION WAS DUE TO THE MOVEMENT OF PATIENT. THERE WAS NO JMS AVF WINGEATER NEEDLE DISLODGEMENT FROM PATIENT ACCESS AS RECONFIRMED BY USER-FACILITY STAFF. THE BLOOD LEAKAGE CAME FROM THE CONNECTION TO THE BLOODLINE. WHEN THE BLOODLINE WAS CHANGED AND RECONNECTED TO THE JMS AVF WINGEATER NEEDLE, THE PATIENT WAS ABLE TO COMPLETE HIS TREATMENT WITHOUT FURTHER INCID

  Patient problems: Blood Loss

  MAUDE report 6903244 ↗