GranuFlo 0FD2251-3BRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00840861101535), received between Jul 12, 2017 and Jul 19, 2019 — classified as 1 death, 19 injuries.

2 FDA recall records name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jul 14, 2026Open, Classified

   Complaints of blue-green discoloration in product

   Z-3091-2026 · Root cause: Material/Component Contamination · FDA record ↗

2. Apr 28, 2021Terminated

   Exposed to freezing temperatures due to refrigerated truck malfunctions

   Z-2086-2021 · Root cause: Environmental control · FDA record ↗

Most reported problems

Recent adverse event reports

The 20 most recent of 20 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 8808569 ↗
• 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 8808258 ↗
• 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 8808078 ↗
• 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 8806934 ↗
• 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 8806751 ↗
• 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 8804772 ↗
• 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 8804752 ↗
• 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 8804558 ↗
• 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 8804293 ↗
• 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 8803934 ↗
• 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 8803836 ↗
• 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 - (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 VISIB

  Patient problems: Hemolysis

  MAUDE report 8802869 ↗
• 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 - (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

  Patient problems: Hemolysis

  MAUDE report 8802618 ↗
• 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 8802026 ↗
• InjuryApr 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019 A HEMODIALYSIS (HD) CLINIC REPORTED AN ISSUE WITH THE SPECIFIC GRAVITY OF THE GRANUFLO BATCH BEING OUT OF SPECIFICATION. IT WAS REPORTED THAT THE GRANUFLO WAS WITHIN SPECIFICATION (1.192M/ML; REFERENCE RANGE 1.190-1.202 G/ML) WHEN TESTED IN THE MIXER ON (B)(6) 2019 AND AGAIN WHEN MOVED TO THE HOLDING TANK (1.200 G/ML). HOWEVER, ON (B)(6) 2019 MULTIPLE HD MACHINES ALARMED FOR CONDUCTIVITY OUT OF RANGE ISSUES. WHEN THE GRANUFLO WAS TESTED AGAIN IN THE HOLDING TANK ON (B)(6) 2019 THE SPECIFIC GRAVITY WAS 1.206 G/ML WHICH IS OUT OF SPECIFICATION. THE SOLUTION WAS CONTINUED TO BE UTILIZED THROUGH 1ST AND 2ND SHIFT ON (B)(6) 2019. THE SOLUTION WAS THEN DISCARDED AND THE SYSTEM WAS FLUSHED. A NEW BATCH WAS MIXED, UTILIZING ANOTHER CLINIC¿S MIXER. THERE WAS A PREVIOUS ISSUE WITH THE MIXER AT THIS HD CLINIC IMPROPERLY MIXING A BATCH OF GRANUFLO ON (B)(6) 2019, WHICH WAS INVESTIGATED IN A SEPARATE COMPLAINT. THAT BATCH HAD BEEN DRAINED AND NO PATIENT WAS DIALYZED WITH THE BATCH. IT WAS REPORTED THAT THIS UNIDENTIFIED PATIENT¿S LAB RESULTS (DATE UNKNOWN) SHOWED ELEVATED POTASSIUM LEVELS (UNKNOWN VALUE) ALLEGEDLY AS A RESULT OF BEING DIALYZED WITH THE SUSPECT BATCH OF GRANUFLO O

  Patient problems: Electrolyte Imbalance

  MAUDE report 8498966 ↗
• InjuryApr 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019 A HEMODIALYSIS (HD) CLINIC REPORTED AN ISSUE WITH THE SPECIFIC GRAVITY OF THE GRANUFLO BATCH BEING OUT OF SPECIFICATION. IT WAS REPORTED THAT THE GRANUFLO WAS WITHIN SPECIFICATION (1.192M/ML; REFERENCE RANGE 1.190-1.202 G/ML) WHEN TESTED IN THE MIXER ON (B)(6) 2019 AND AGAIN WHEN MOVED TO THE HOLDING TANK (1.200 G/ML). HOWEVER, ON (B)(6) 2019 MULTIPLE HD MACHINES ALARMED FOR CONDUCTIVITY OUT OF RANGE ISSUES. WHEN THE GRANUFLO WAS TESTED AGAIN IN THE HOLDING TANK ON (B)(6) 2019 THE SPECIFIC GRAVITY WAS 1.206 G/ML WHICH IS OUT OF SPECIFICATION. THE SOLUTION WAS CONTINUED TO BE UTILIZED THROUGH 1ST AND 2ND SHIFT ON (B)(6) 2019. THE SOLUTION WAS THEN DISCARDED AND THE SYSTEM WAS FLUSHED. A NEW BATCH WAS MIXED, UTILIZING ANOTHER CLINIC¿S MIXER. THERE WAS A PREVIOUS ISSUE WITH THE MIXER AT THIS HD CLINIC IMPROPERLY MIXING A BATCH OF GRANUFLO ON (B)(6) 2019, WHICH WAS INVESTIGATED IN A SEPARATE COMPLAINT. THAT BATCH HAD BEEN DRAINED AND NO PATIENT WAS DIALYZED WITH THE BATCH. IT WAS REPORTED THAT THIS UNIDENTIFIED PATIENT¿S LAB RESULTS (DATE UNKNOWN) SHOWED ELEVATED POTASSIUM LEVELS (UNKNOWN VALUE) ALLEGEDLY AS A RESULT OF BEING DIALYZED WITH THE SUSPECT BATCH OF GRANUFLO O

  Patient problems: Electrolyte Imbalance

  MAUDE report 8498912 ↗
• InjuryApr 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019 A HEMODIALYSIS (HD) CLINIC REPORTED AN ISSUE WITH THE SPECIFIC GRAVITY OF THE GRANUFLO BATCH BEING OUT OF SPECIFICATION. IT WAS REPORTED THAT THE GRANUFLO WAS WITHIN SPECIFICATION (1.192M/ML; REFERENCE RANGE 1.190-1.202 G/ML) WHEN TESTED IN THE MIXER ON (B)(6) 2019 AND AGAIN WHEN MOVED TO THE HOLDING TANK (1.200 G/ML). HOWEVER, ON (B)(6) 2019 MULTIPLE HD MACHINES ALARMED FOR CONDUCTIVITY OUT OF RANGE ISSUES. WHEN THE GRANUFLO WAS TESTED AGAIN IN THE HOLDING TANK ON (B)(6) 2019 THE SPECIFIC GRAVITY WAS 1.206 G/ML WHICH IS OUT OF SPECIFICATION. THE SOLUTION WAS CONTINUED TO BE UTILIZED THROUGH 1ST AND 2ND SHIFT ON (B)(6) 2019. THE SOLUTION WAS THEN DISCARDED AND THE SYSTEM WAS FLUSHED. A NEW BATCH WAS MIXED, UTILIZING ANOTHER CLINIC¿S MIXER. THERE WAS A PREVIOUS ISSUE WITH THE MIXER AT THIS HD CLINIC IMPROPERLY MIXING A BATCH OF GRANUFLO ON (B)(6) 2019, WHICH WAS INVESTIGATED IN A SEPARATE COMPLAINT. THAT BATCH HAD BEEN DRAINED AND NO PATIENT WAS DIALYZED WITH THE BATCH. IT WAS REPORTED THAT THIS UNIDENTIFIED PATIENT¿S LAB RESULTS (DATE UNKNOWN) SHOWED ELEVATED POTASSIUM LEVELS (UNKNOWN VALUE) ALLEGEDLY AS A RESULT OF BEING DIALYZED WITH THE SUSPECT BATCH OF GRANUFLO O

  Patient problems: Electrolyte Imbalance

  MAUDE report 8498839 ↗
• InjuryApr 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019 A HEMODIALYSIS (HD) CLINIC REPORTED AN ISSUE WITH THE SPECIFIC GRAVITY OF THE GRANUFLO BATCH BEING OUT OF SPECIFICATION. IT WAS REPORTED THAT THE GRANUFLO WAS WITHIN SPECIFICATION (1.192M/ML; REFERENCE RANGE 1.190-1.202 G/ML) WHEN TESTED IN THE MIXER ON (B)(6) 2019 AND AGAIN WHEN MOVED TO THE HOLDING TANK (1.200 G/ML). HOWEVER, ON (B)(6) 2019, MULTIPLE HD MACHINES ALARMED FOR CONDUCTIVITY OUT OF RANGE ISSUES. WHEN THE GRANUFLO WAS TESTED AGAIN IN THE HOLDING TANK ON (B)(6) 2019, THE SPECIFIC GRAVITY WAS 1.206 G/ML WHICH IS OUT OF SPECIFICATION. THE SOLUTION CONTINUED TO BE UTILIZED THROUGH 1ST AND 2ND SHIFT ON (B)(6) 2019. THE SOLUTION WAS THEN DISCARDED, AND THE SYSTEM WAS FLUSHED. A NEW BATCH WAS MIXED, UTILIZING ANOTHER CLINIC¿S MIXER. THERE WAS A PREVIOUS ISSUE WITH THE MIXER AT THIS HD CLINIC IMPROPERLY MIXING A BATCH OF GRANUFLO ON (B)(6) 2019, WHICH WAS INVESTIGATED IN A SEPARATE COMPLAINT. THAT BATCH HAD BEEN DRAINED AND NO PATIENT WAS DIALYZED WITH THE BATCH. IT WAS REPORTED THAT THIS (B)(6) YEAR OLD MALE PATIENT EXPERIENCED HYPERKALEMIA, ALLEGEDLY AS A RESULT OF BEING DIALYZED WITH THE SUSPECT BATCH OF GRANUFLO ON (B)(6) 2019. THE PATIENT ALSO COMPLETED TRE

  Patient problems: Electrolyte Imbalance

  MAUDE report 8497540 ↗
• DeathOct 15, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL AT A USER FACILITY REPORTED THAT A PATIENT PASSED AWAY FOLLOWING TREATMENT ON A FRESENIUS 2008T HEMODIALYSIS (HD) MACHINE. PRIOR TO TREATMENT, THE PATIENT HAD A RECORDED BLOOD PRESSURE OF 125/78 AND A PULSE OF 84 BEATS PER MINUTE. THE PATIENT¿S RESPIRATORY MEASUREMENT WAS 18. THE PATIENT INITIATED TREATMENT VIA A RIGHT TUNNELED JUGULAR CATHETER WITHOUT COMPLAINT AT ABOUT 15:36. THE PATIENT RECEIVED DIALYSATE VIA A CENTRAL FEED. THIRTY MINUTES INTO TREATMENT, THE PATIENT WAS REPORTED TO BE RESTING COMFORTABLY. AT ABOUT 16:27, THE PATIENT WAS ADMINISTERED DOSES OF MIRCERA (50MCG, IVP), VENOFER (100MG, IVP), AND HECTOROL (2.0MCG, IVP). APPROXIMATELY THREE MINUTES LATER, THE PATIENT REPORTED THAT THEY WERE NOT FEELING WELL AND WERE UNABLE TO BREATHE. THE PATIENT BECAME PALE, DIAPHORETIC AND UNRESPONSIVE. TREATMENT WAS DISCONTINUED. THE USER FACILITY CALLED 911 AND THE PATIENT CODED. THE AUTOMATED EXTERNAL DEFIBRILLATOR DETECTED NO RHYTHM AND THREE ROUNDS OF CPR WERE PERFORMED. THE AMBULANCE ARRIVED AND THE PATIENT WAS TRANSPORTED TO THE HOSPITAL EMERGENCY ROOM. THE PATIENT SUBSEQUENTLY PASSED AWAY. UPON FOLLOW UP WITH THE USER FACILITY, IT WAS NOTED THAT THERE

  Patient problems: Death

  MAUDE report 6950589 ↗
• 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 6708961 ↗