NaturaLyte 08-4112-2Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00840861101955), received between Jun 26, 2017 and Jul 19, 2019 — classified as 1 death, 23 injuries.

1 FDA recall record name this device's identifier.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Apr 28, 2021Terminated

   Exposed to freezing temperatures due to refrigerated truck malfunctions

   Z-2087-2021 · Root cause: Environmental control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryJul 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 NO VIS

  Patient problems: Hemolysis

  MAUDE report 8808478 ↗
• InjuryJul 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 12.8 TO 11.2. THE PATIENT REQUIRED A BLOOD TRANSFUSION ON (B)(6) 2019 OUTPATIENT DUE TO AN UNKNOWN SURGICAL PROCEDURE; HOWEVER, THEY WERE NOT ADMITTED TO THE HOSPITAL. 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 EVENTS AND/OR DIALYZER LEAKS IN RELATION TO THE HEMOLYSIS EVENT. IT WAS REPORTED THERE WAS NOTHING UNUSUAL IN ANY OF

  Patient problems: Hemolysis

  MAUDE report 8808204 ↗
• InjuryJul 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 10.6 TO 8.4. THE PATIENT WAS ADMITTED INTO THE HOSPITAL ON (B)(6) 2019 WITH A HEMOGLOBIN OF 6.7 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

  Patient problems: Hemolysis

  MAUDE report 8807855 ↗
• InjuryJul 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 12.5 TO 11.1. THE PATIENT WAS ADMITTED INTO THE HOSPITAL 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 PRODUCTS USED, A

  Patient problems: Hemolysis

  MAUDE report 8807225 ↗
• InjuryJul 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 WAS NOT DIALYZING IN THE CLINIC ON (B)(6) 2019 AND (B)(6) 2019 BECAUSE THE PATIENT WAS IN THE HOSPITAL DUE TO A PLANNED LOWER EXTREMITY AMPUTATION (NOT RELATED TO HEMODIALYSIS OR ANY FRESENIUS PRODUCTS). THE PATIENT¿S PRE-HEMODIALYSIS TREATMENT LABS WERE DRAWN ON (B)(6) 2019 WITHOUT ANY REPORTED ISSUES WITH THE LAB SPECIMEN. THE PATIENT¿S HEMOGLOBIN WAS 10.2 ON (B)(6) 2019. THE PATIENT WAS REPORTED DIALYZING ON (B)(6) 2019 AND (B)(6) 2019 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. 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 TO 8.8. THE PATIENT REQUIRED A BLOOD TRANSFUSION ON (B)(6) 2019; HOWEVER, THEY WERE NOT ADMITTED TO THE HOSPITAL. THE PATIENT¿S HEMOGLOBI

  Patient problems: Hemolysis

  MAUDE report 8806776 ↗
• InjuryJul 18, 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 EVENTS A

  Patient problems: Hemolysis

  MAUDE report 8804873 ↗
• InjuryJul 18, 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 9.9 TO 8.1. THE PATIENT WAS ADMITTED INTO THE HOSPITAL ON (B)(6) 2019 WITH A HEMOGLOBIN OF 7.1 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 DIALYZER, 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 A

  Patient problems: Hemolysis

  MAUDE report 8804729 ↗
• InjuryJul 18, 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 S HEMOGLOBIN OF 9 ON (B)(6) 2019 AND (B)(6) 2019. THE PATIENT WAS ADMITTED INTO THE HOSPITAL WITH HEMOGLOBIN OF 8.9 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. THE PATIENT¿S HEMOGLOBIN IMPROVED TO 9.9 ON (B)(6) 2019. REPORTEDLY, THE PATIENT CONTINUES TO RECEIVE HEMODIALYSIS TREATMENTS. 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

  Patient problems: Hemolysis

  MAUDE report 8804584 ↗
• InjuryJul 18, 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 8.7 TO 8.4. THE PATIENT WAS ADMITTED INTO THE HOSPITAL ON (B)(6) 2019 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. IT WAS REPORTED THERE WERE NO

  Patient problems: Hemolysis

  MAUDE report 8804202 ↗
• InjuryJul 18, 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 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 ANYTHING UNEXPECT

  Patient problems: Hemolysis

  MAUDE report 8804112 ↗
• InjuryJul 18, 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 10.8 TO 6.4. 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. THE PATIENT¿S HEMOGLOBIN IMPROVED TO 9.9 ON (B)(6) 2019. 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

  Patient problems: Hemolysis

  MAUDE report 8803380 ↗
• InjuryJul 18, 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 HE

  Patient problems: Hemolysis

  MAUDE report 8802844 ↗
• InjuryJul 18, 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 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 AS NO MACHINE ALARM

  Patient problems: Hemolysis

  MAUDE report 8802423 ↗
• InjuryJul 18, 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. THE PATIENT WAS ADMITTED INTO THE HOSPITAL ON (B)(6) 2019 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 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

  Patient problems: Hemolysis

  MAUDE report 8802150 ↗
• InjuryApr 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED NAUSEA DURING HEMODIALYSIS TREATMENT. A BIOMED TECHNICIAN REPORTED THAT THE BATCH OF NATURALYTE WAS MIXED IMPROPERLY AND CAUSED THE SYMPTOMS IN THE PATIENT. DURING FOLLOW UP WITH THE BIOMED TECHNICIAN IT WAS REPORTED THAT THE NATURALYTE WAS MIXED DURING THE MORNING SHIFT, AND WAS POSSIBLE THERE WERE INCORRECT QUANTITIES MIXED. THERE WERE NO ALARMS. THE CONDUCTIVITY OF THE MACHINE WAS CHECKED AND READ 13.0-13.1. THE CLINIC MANAGER STATED THAT THE PATIENT WAS ABLE TO COMPLETE TREATMENT. THE CLINIC MANAGER STATED THAT A BLOOD TEST WAS PERFORMED AND REVEALED THAT THE BICARBONATE LEVELS WERE SIGNIFICANTLY LOWERED.

  Patient problems: Nausea

  MAUDE report 7443772 ↗
• InjuryApr 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED CRAMPING DURING HEMODIALYSIS TREATMENT. A BIOMED TECHNICIAN REPORTED THAT THE BATCH OF NATURALYTE WAS MIXED IMPROPERLY AND CAUSED THE SYMPTOMS IN THE PATIENT. DURING FOLLOW UP WITH THE BIOMED TECHNICIAN IT WAS REPORTED THAT THE NATURALYTE WAS MIXED DURING THE MORNING SHIFT, AND WAS POSSIBLE THERE WERE INCORRECT QUANTITIES MIXED. THERE WERE NO ALARMS. THE CONDUCTIVITY OF THE MACHINE WAS CHECKED AND READ 13.0-13.1. THE CLINIC MANAGER STATED THAT THE PATIENT WAS ABLE TO COMPLETE TREATMENT. THE CLINIC MANAGER STATED THAT A BLOOD TEST WAS PERFORMED AND REVEALED THAT THE BICARBONATE LEVELS WERE SIGNIFICANTLY LOWERED.

  Patient problems: Cramp(s)

  MAUDE report 7441725 ↗
• InjuryApr 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED VOMITING AND NAUSEA DURING HEMODIALYSIS TREATMENT. A BIOMED TECHNICIAN REPORTED THAT THE BATCH OF NATURALYTE WAS MIXED IMPROPERLY AND CAUSED THE SYMPTOMS IN THE PATIENT. DURING FOLLOW UP WITH THE BIOMED TECHNICIAN IT WAS REPORTED THAT THE NATURALYTE WAS MIXED DURING THE MORNING SHIFT, AND WAS POSSIBLE THERE WERE INCORRECT QUANTITIES MIXED. THERE WERE NO ALARMS. THE CONDUCTIVITY OF THE MACHINE WAS CHECKED AND READ 13.0-13.1. THE CLINIC MANAGER STATED THAT THE PATIENT WAS ABLE TO COMPLETE TREATMENT. THE CLINIC MANAGER STATED THAT A BLOOD TEST WAS PERFORMED AND REVEALED THAT THE BICARBONATE LEVELS WERE SIGNIFICANTLY LOWERED.

  Patient problems: Nausea; Vomiting

  MAUDE report 7441700 ↗
• InjuryApr 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED CRAMPING DURING HEMODIALYSIS TREATMENT. A BIOMED TECHNICIAN REPORTED THAT THE BATCH OF NATURALYTE WAS MIXED IMPROPERLY AND CAUSED THE SYMPTOMS IN THE PATIENT. DURING FOLLOW UP WITH THE BIOMED TECHNICIAN IT WAS REPORTED THAT THE NATURALYTE WAS MIXED DURING THE MORNING SHIFT, AND WAS POSSIBLE THERE WERE INCORRECT QUANTITIES MIXED. THERE WERE NO ALARMS. THE CONDUCTIVITY OF THE MACHINE WAS CHECKED AND READ 13.0-13.1. THE CLINIC MANAGER STATED THAT THE PATIENT WAS ABLE TO COMPLETE TREATMENT. THE CLINIC MANAGER STATED THAT A BLOOD TEST WAS PERFORMED AND REVEALED THAT THE BICARBONATE LEVELS WERE SIGNIFICANTLY LOWERED.

  Patient problems: Cramp(s)

  MAUDE report 7441690 ↗
• InjuryApr 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED DROPPING BLOOD PRESSURE DURING HEMODIALYSIS TREATMENT. A BIOMED TECHNICIAN REPORTED THAT THE BATCH OF NATURALYTE WAS MIXED IMPROPERLY AND CAUSED THE SYMPTOMS IN THE PATIENT. DURING FOLLOW UP WITH THE BIOMED TECHNICIAN IT WAS REPORTED THAT THE NATURALYTE WAS MIXED DURING THE MORNING SHIFT, AND WAS POSSIBLE THERE WERE INCORRECT QUANTITIES MIXED. THERE WERE NO ALARMS. THE CONDUCTIVITY OF THE MACHINE WAS CHECKED AND READ 13.0-13.1. THE CLINIC MANAGER STATED THAT THE PATIENT WAS ABLE TO COMPLETE TREATMENT. THE CLINIC MANAGER STATED THAT A BLOOD TEST WAS PERFORMED AND REVEALED THAT THE BICARBONATE LEVELS WERE SIGNIFICANTLY LOWERED.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 7441655 ↗
• InjuryApr 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED VOMITING DURING HEMODIALYSIS TREATMENT. A BIOMED TECHNICIAN REPORTED THAT THE BATCH OF NATURALYTE WAS MIXED IMPROPERLY AND CAUSED THE SYMPTOMS IN THE PATIENT. DURING FOLLOW UP WITH THE BIOMED TECHNICIAN IT WAS REPORTED THAT THE NATURALYTE WAS MIXED DURING THE MORNING SHIFT, AND WAS POSSIBLE THERE WERE INCORRECT QUANTITIES MIXED. THERE WERE NO ALARMS. THE CONDUCTIVITY OF THE MACHINE WAS CHECKED AND READ 13.0-13.1. THE CLINIC MANAGER STATED THAT THE PATIENT WAS ABLE TO COMPLETE TREATMENT. THE CLINIC MANAGER STATED THAT A BLOOD TEST WAS PERFORMED AND REVEALED THAT THE BICARBONATE LEVELS WERE SIGNIFICANTLY LOWERED.

  Patient problems: Vomiting

  MAUDE report 7441622 ↗
• InjuryApr 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED NAUSEA DURING HEMODIALYSIS TREATMENT. A BIOMED TECHNICIAN REPORTED THAT THE BATCH OF NATURALYTE WAS MIXED IMPROPERLY AND CAUSED THE SYMPTOMS IN THE PATIENT. DURING FOLLOW UP WITH THE BIOMED TECHNICIAN IT WAS REPORTED THAT THE NATURALYTE WAS MIXED DURING THE MORNING SHIFT, AND WAS POSSIBLE THERE WERE INCORRECT QUANTITIES MIXED. THERE WERE NO ALARMS. THE CONDUCTIVITY OF THE MACHINE WAS CHECKED AND READ 13.0-13.1. THE CLINIC MANAGER STATED THAT THE PATIENT WAS ABLE TO COMPLETE TREATMENT. THE CLINIC MANAGER STATED THAT A BLOOD TEST WAS PERFORMED AND REVEALED THAT THE BICARBONATE LEVELS WERE SIGNIFICANTLY LOWERED.

  Patient problems: Nausea

  MAUDE report 7440042 ↗
• InjuryApr 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED LOW BLOOD PRESSURE AND FEELING FAINT DURING HEMODIALYSIS TREATMENT. A BIOMED TECHNICIAN REPORTED THAT THE BATCH OF NATURALYTE WAS MIXED IMPROPERLY AND CAUSED THE SYMPTOMS IN THE PATIENT. DURING FOLLOW UP WITH THE BIOMED TECHNICIAN IT WAS REPORTED THAT THE NATURALYTE WAS MIXED DURING THE MORNING SHIFT, AND WAS POSSIBLE THERE WERE INCORRECT QUANTITIES MIXED. THERE WERE NO ALARMS. THE CONDUCTIVITY OF THE MACHINE WAS CHECKED AND READ 13.0-13.1. THE CLINIC MANAGER STATED THAT THE PATIENT WAS GIVEN AN UNKNOWN DOSE OF SALINE FOR THE LOW BLOOD PRESSURE. THE CLINIC MANAGER STATED THAT THE PATIENT WAS ABLE TO COMPLETE TREATMENT. THE CLINIC MANAGER STATED THAT A BLOOD TEST WAS PERFORMED AND REVEALED THAT THE BICARBONATE LEVELS WERE SIGNIFICANTLY LOWERED.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 7439898 ↗
• InjuryJul 12, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEMODIALYSIS (HD) NURSE AT THE USER FACILITY REPORTED THAT A FEMALE, END STAGE RENAL DISEASE (ESRD) PATIENT CARDIAC ARRESTED 32 MINUTES PRIOR TO COMPLETION OF A REGULARLY SCHEDULED HD TREATMENT. THIS ESRD PATIENT HAD BEEN UTILIZING HD THERAPY THRICE WEEKLY FOR CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) SINCE (B)(6) 2015. THE PATIENTS¿ SCHEDULED HD TREATMENT ON (B)(6) 2017 WAS INITIATED AT 05:29. THE HD TREATMENT CONTINUED THROUGH 08:01 WITH STABLE VITAL SIGNS (VS), 2 LITER (L) PER MINUTE (MIN) OXYGEN (O2) VIA NASAL CANNULA (OXYGEN IS A STANDING ORDER FOR PATIENT), WITH PATIENT RESTING COMFORTABLY THROUGHOUT HD TREATMENT. AT 08:28 THE PATIENT WAS FOUND UNRESPONSIVE; NO PULSE OR RESPIRATIONS. THE PATIENTS¿ BLOOD WAS RETURNED WITH A NORMAL SALINE (NACL) BOLUS (AMOUNT UNKNOWN). NO BLOOD LOSS OCCURRED. THE PATIENT WAS TRANSFERRED FROM THE CHAIR TO THE FLOOR AND CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED WITH AN AMBU BAG. AT 08:36, AN AUTOMATED EXTERNAL DEFIBRILLATOR (AED) WAS ATTACHED TO THE PATIENT AND A SHOCK WAS ADVISED AND DELIVERED. CPR RESUMED. AT 08:38, A RADIAL PULSE WAS PALPATED. AT 08:41, EPINEPHRINE [1:1000/1 MILLILITER (ML)] VIA INTRAVENOUS PUSH (IVP) WAS ADMINIS

  Patient problems: Cardiac Arrest

  MAUDE report 6708978 ↗
• DeathJun 26, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CLINIC MANAGER AT A USER FACILITY REPORTED THAT DURING A HEMODIALYSIS (HD) TREATMENT ON (B)(6)2017, APPROXIMATELY 7 MINUTES AFTER THE INITIATION OF TREATMENT, THE PATIENT LOST CONSCIOUSNESS AND BECAME UNRESPONSIVE. CARDIOPULMONARY RESUSCITATION (CPR) EFFORTS WERE INITIATED AND THE FACILITY CALLED EMERGENCY MEDICAL SERVICES (EMS). EMS PERSONNEL TRANSFERRED THE PATIENT TO EMERGENCY CARE AT A MEDICAL CENTER, WHO LATER NOTIFIED THE FACILITY OF THE PATIENT¿S DEATH. FOLLOW-UP INFORMATION REVEALED THAT THE PATIENT HAD INITIALLY BEEN ADMITTED TO THE HOSPITAL ON (B)(6)2017 FOR AGGRESSIVE WOUND TREATMENT OF THE LEFT FOOT AND HAD BEEN PREPPED FOR HD THERAPY FOR AGGRESSIVE VOLUME REMOVAL AND UREMIC TOXIN REMOVAL. PRIOR TO THE HOSPITALIZATION, THE PATIENT HAD BEEN AT A REHABILITATION CENTER FOR ALMOST A MONTH FOLLOWING A RIGHT HIP FRACTURE WITH SURGICAL REPAIR. HOWEVER, THE PATIENT HAD WORSENING ANASARCA, HYPOXEMIA, DYSPNEA ON EXERTION REQUIRING SUPPLEMENTAL OXYGEN, AND WEAKNESS LEADING TO THE HOSPITALIZATION OF (B)(6)2017. DURING THE HOSPITALIZATION, THE PATIENT HAD WEAKNESS, FATIGUE, SHORTNESS OF BREATH, DYSPNEA ON EXERTION, ORTHOPNEA, FOAMY URINE, 4+ EDEMA (LEFT GREATER THEN RIGHT), WEEPIN

  Patient problems: Cardiac Arrest; Death; Loss of consciousness

  MAUDE report 6667988 ↗