JMS WINGEATER A.V.FISTULA NEEDLE SETRecalls & reported problems across all models

We found 3 models of JMS WINGEATER A.V.FISTULA NEEDLE SET by Jms Singapore Pte Ltd in the FDA's device registry (GUDID). Together they are named in 32 adverse event reports in the FDA's MAUDE database, received between Apr 4, 2017 and Sep 19, 2024 — classified as 8 deaths, 24 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (10 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported JMS WINGEATER A.V.FISTULA NEEDLE SET problems

JMS WINGEATER A.V.FISTULA NEEDLE SET models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• JMS WINGEATER A.V.FISTULA NEEDLE SET 820-5002-33

  Needle, Fistula
  6 deaths27 reports
• JMS WINGEATER A.V.FISTULA NEEDLE SET 820-7005-33

  Needle, Fistula
  2 deaths4 reports
• JMS WINGEATER A.V.FISTULA NEEDLE SET 820-5003-33

  Needle, Fistula
  1 report

Recent JMS WINGEATER A.V.FISTULA NEEDLE SET adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 19, 2024Material Fragmentation; Material Fragmentation

  THE DONOR DONATED ON (B)(6) 2024, WITH NO COMPLICATIONS NOTED WHILE HE WAS IN THE PLASMA CENTER. ON (B)(6) 2024, THE DONOR EXPERIENCED ARM DISCOMFORT AROUND THE VENIPUNCTURE (VP) SITE, INITIALLY ATTRIBUTING IT TO A WORKOUT. DESPITE THE DONOR'S USE OF ICE AND HEAT, THE DISCOMFORT DID NOT RESOLVE. THE DONOR VISITED THE ER ON (B)(6) 2024, WHERE HE REPORTED THAT AN X-RAY OF THE LEFT FOREARM REVEALED THAT PART OF THE NEEDLE WAS BENEATH THE VP SITE. THE MSS (PHYSICIAN SUBSTITUTE) ADVISED THE DONOR TO PROVIDE MEDICAL RECORDS AND A BIOLIFE MSS WOULD FOLLOW UP. CURRENTLY, THE DONOR HAS NOT PROVIDED ANY ADDITIONAL INFORMATION OR MEDICAL RECORDS. IMPORTER IS IN COMMUNICATION WITH FACILITY AND TRYING TO GET THE NEEDLE BACK TO MANUFACTURER AFTER IT IS EXTRACTED FROM PATIENT TO ENSURE THIS IS JMS NEEDLE. AT THIS POINT THERE HAS BEEN NO UPDATE FROM PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 20263857 ↗
• 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 ↗