Optiflux® 0500325ERecalls & reported problems

Summary

The FDA's MAUDE database contains 198 adverse event reports that list this exact device (DI 00840861100170), received between May 31, 2017 and Sep 30, 2026 — classified as 1 death, 7 injuries, 190 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (174 reports).

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

Recalls naming this device

1. Aug 29, 2025Open, Classified

   To provide further information to the user to ensure proper use of the medical device. the caps had been changed from a threaded version to a press-on version whereby the user must press the caps firmly onto the dialyzer to securely affix the cap.

   Z-0041-2026 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 198 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Fluid/Blood Leak

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50951708 ↗
• MalfunctionSep 17, 2026Fluid/Blood Leak

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50812328 ↗
• MalfunctionAug 26, 2026Obstruction of Flow

  A user facility¿s medical instrument technician reported that a FME Optiflux dialyzer experienced blood flowing back out of the dialyzer when the machine flow was turned on. When the flow was turned off, the dialyzer filled back up with blood. This occurred two hours after the initiation of a patient¿s hemodialysis (HD) treatment. The machine, a FME 2008T machine, did not alarm but was not expected to. The machine was removed from service following the incident and no issues were found. The machine was returned to service and has not had any issues since. A FME bloodline was in use. There was no obvious defect or damage seen on the dialyzer. The patient¿s blood was not returned following the incident and their estimated blood loss (EBL) was approximately 300mL. The patient was restarted on a new machine and treatment completed successfully with new supplies. There was no patient injury or medical intervention required due to the reported event. The complaint device is available to be returned to the manufacturer for evaluation. Multiple attempts have been made to contact the customer to obtain additional information related to the reported event. At this time, no additional informa

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50457954 ↗
• MalfunctionAug 24, 2026Fluid/Blood Leak

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50409052 ↗
• MalfunctionJul 8, 2026Fluid/Blood Leak

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25750504 ↗
• MalfunctionJul 2, 2026Fluid/Blood Leak

  A DIALYSIS MANAGER REPORTED TO FRESENIUS THAT A DIALYZER BLOOD LEAK OCCURRED DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOW-UP. THE BLOOD LEAK OCCURRED A LITTLE OVER ONE HOUR INTO THE TREATMENT. THE BLOOD LEAK WAS REPORTED TO BE INTERNAL, AND IT WAS CONFIRMED TO BE VISUALLY OBSERVED. THE MACHINE, A FRESENIUS 2008T MACHINE, ALARMED APPROPRIATELY WITH A BLOOD LEAK ALARM. A BLOOD LEAK TEST STRIP WAS NOT USED. THERE WAS NO DAMAGE OR DEFECT NOTED ON THE DIALYZER. FRESENIUS BLOODLINES WERE ALSO BEING USED. AFTER THE LEAK OCCURRED, THE LINES WERE CLAMPED OFF AND THE TREATMENT WAS STOPPED. THE PATIENT¿S BLOOD WAS NOT RETURNED; ESTIMATED BLOOD LOSS (EBL) WAS 200 TO 250 ML. IT WAS CONFIRMED THERE WAS NO PATIENT SERIOUS INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. THE PATIENT COMPLETED THEIR TREATMENT AFTER BEING RE-SETUP WITH NEW SUPPLIES ON A DIFFERENT MACHINE. THE SAMPLE WAS NOT AVAILABLE TO BE RETURNED FOR MANUFACTURER EVALUATION AS IT WAS REPORTEDLY DISCARDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25691375 ↗
• MalfunctionJun 25, 2026Fluid/Blood Leak

  A USER FACILITY NURSE REPORTED THAT A DIALYZER BLOOD LEAK OCCURRED APPROXIMATELY THREE HOURS AFTER THE START OF TREATMENT. THE BLOOD LEAK WAS REPORTED TO BE EXTERNAL. THE BLOOD LEAK (AS DESCRIBED) WAS COMING FROM THE CONNECTION OF THE HEADER/END-CAP TO THE BODY OF THE DEVICE, AS DEPICTED IN A PROVIDED DIAGRAM. NO ALARM OCCURRED. THE MACHINE IN USE WAS A FRESENIUS 5008. FRESENIUS BLOODLINES WERE ALSO IN USE. THERE WAS NO DAMAGE OBSERVED ON THE DIALYZER. IT WAS REPORTEDLY NOT POSSIBLE TO QUANTIFY THE AMOUNT OF BLOOD LOSS THE PATIENT EXPERIENCED. THE PATIENT DID NOT COMPLETE THEIR TREATMENT; THEY RAN FOR THREE HOURS INSTEAD OF FOUR HOURS. THERE WAS NO REPORT OF ANY SERIOUS PATIENT INJURY OR HARM DUE TO THE BLOOD LEAK EVENT. THE SAMPLE WAS CONFIRMED TO BE AVAILABLE TO BE RETURNED FOR MANUFACTURER EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25619590 ↗
• MalfunctionMay 26, 2026Fluid/Blood Leak

  A RISK MANAGER REPORTED, THROUGH A MEDWATCH REPORT (5187562), THAT THERE WAS A DIALYZER BLOOD LEAK DURING A HEMODIALYSIS (HD) TREATMENT. ADDITIONAL INFORMATION WAS RECEIVED FROM A DIALYSIS TECHNICIAN THE LEAK OCCURRED IMMEDIATELY AT STARTING THE HEMODIALYSIS (HD) TREATMENT WHEN THE BLOOD HIT THE DIALYZER. THE NURSE EXPLAINED THAT THE LEAK WAS VISUALLY SEEN TOWARD THE HEAD OF THE DIALYZER¿IN DIALYSATE COMPARTMENT. THE BLOOD LEAK WAS DESCRIBED AS BEING AN INTERNAL BLOOD LEAK. A FRESENIUS 2008T MACHINE WAS BEING USED. FRESENIUS BLOODLINES WERE BEING USED. BLOOD LEAK TEST STRIPS WERE NOT USED. THERE WAS NO DAMAGE NOTED ON THE DIALYZER. THERE WAS PATIENT BLOOD LOSS ESTIMATED TO BE 88CC. THERE WAS NO PATIENT INJURY, ADVERSE EVENT OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT OTHER THAN THE MINIMAL BLOOD LOSS INDICATED. THE PATIENT FINISHED TREATMENT ON A THE SAME MACHINE WITH NEW SUPPLIES. THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25291835 ↗
• MalfunctionMay 14, 2026Fluid/Blood Leak

  A REGIONAL DIRECTOR OF DIALYSIS REPORTED TO FRESENIUS THAT AN OPTIFLUX 250NRE DIALYZER WAS NOT FILLING WITH BLOOD DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE REPORTED EVENT REQUIRED THE STAFF TO RESTRING THE MACHINE WITH NEW SUPPLIES. ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOW-UP WITH THE CLINICAL MANAGER (CM) FROM THE FACILITY WHERE THE EVENT OCCURRED. THE CM STATED BLOOD WAS NOT PASSING THROUGH THE DIALYZER AT THE START OF A PATIENT¿S TREATMENT. PRIOR TO TREATMENT INITIATION, THE CIRCUIT WAS PRIMED WITH NO ISSUES NOTED. THE PATIENT WAS UTILIZING AN OPTIFLUX F250NRE DIALYZER WITH A B. BRAUN STREAMLINE BLOODLINE, AND CONNECTED TO A B. BRAUN HD MACHINE. AFTER PRIMING WAS COMPLETED, THE STAFF STARTED THE PATIENT¿S TREATMENT. WHILE MONITORING THE START, THEY SAW BLOOD ENTER THE DIALYZER BUT NOT EXIT. ONLY SALINE WAS BEING PUSHED THROUGH THE BOTTOM OF THE DEVICE. APPROXIMATELY FORTY SECONDS HAD ELAPSED SINCE TREATMENT INITIATION WITH NO CHANGE; BLOOD WAS NOT PASSING THROUGH THE DIALYZER. THE STAFF STOPPED THE BLOOD PUMP TO INSPECT THE SETUP AND CHECK ALL CONNECTIONS. THE CONNECTIONS SEEMED TIGHT AND NO LEAKS WERE NOTED. THERE WERE NO ISSUES WITH THE NEEDLES, AND NOTHING

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25178874 ↗
• MalfunctionMay 14, 2026Fluid/Blood Leak

  A USER FACILITY INVENTORY MANAGER REPORTED A DIALYZER BLOOD LEAK. THE ESTIMATED BLOOD LOSS (EBL) WAS UNKNOWN. THE SAMPLE WAS AVAILABLE TO BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT RECEIVED TO DATE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25176272 ↗
• MalfunctionApr 27, 2026Fluid/Blood Leak

  A SUPPLIES MANAGER REPORTED A DIALYZER BLOOD LEAK ASSOCIATED WITH A HEMODIALYSIS (HD) TREATMENT. THERE WAS NO HARM REPORTED IN THE INITIAL REPORT. A SAMPLE RETURN WAS REQUESTED, BUT NO SAMPLE HAS BEEN RECEIVED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25005069 ↗
• MalfunctionApr 25, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A DIALYZER LEAK OCCURRED WHILE PRIMING AN OPTIFLUX F250NRE DIALYZER FOR HEMODIALYSIS (HD) TREATMENT. THERE WERE NO ALARMS FROM THE MACHINE. THE LEAK OCCURRED BEFORE THE START OF TREATMENT, AND THUS THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT. HOWEVER, THE LEAK RESULTED IN A DELAYED TREATMENT START. THE LEAK WAS COMING FROM THE SEAL OF THE HEADER CAP TO THE BODY OF THE DIALYZER. THERE WAS NO PHYSICAL DAMAGE VISIBLE ON THE DEVICE, AND THE DIALYZER HAD NOT BEEN DROPPED PRIOR TO USE. NO PHOTOS OF THE DIALYZER WERE AVAILABLE FOR REVIEW. THE SAMPLE WAS REPORTED TO BE AVAILABLE FOR MANUFACTURER EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24992015 ↗
• MalfunctionMar 13, 2026Fluid/Blood Leak

  A MEDICAL CENTER RISK MANAGER REPORTED VIA VOLUNTARY MEDWATCH THAT A HEMODIALYSIS (HD) PATIENT UTILIZING AN OPTIFLUX F250NRE DIALYZER EXPERIENCED A DIALYZER BLOOD LEAK. THE BLOOD LEAK REPORTEDLY OCCURRED AT THE INITIATION OF TREATMENT, WHEN BLOOD HIT THE ARTERIAL SIDE OF THE DIALYZER. THE MACHINE ALARMED IMMEDIATELY WITH A BLOOD LEAK ALARM. THE BLOOD LEAK WAS REPORTED TO BE VISUALLY OBSERVED. THE TREATMENT WAS STOPPED, AND BLOOD WAS NOT RETURNED TO THE PATIENT. THE PATIENT WAS DISCONNECTED FROM THE SETUP. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS <100ML. DUE TO THE BLOOD LOSS, THE DOCTOR WAS NOTIFIED. THE PATIENT WAS RELOCATED TO A DIFFERENT MACHINE TO CONTINUE THEIR TREATMENT. THERE WAS NO INDICATION THAT THE PATIENT EXPERIENCED A SERIOUS INJURY, ANY ADVERSE EFFECTS, OR THAT MEDICAL INTERVENTION WAS REQUIRED. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION, AND THUS FAR NO FURTHER DETAILS HAVE BEEN PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24594849 ↗
• MalfunctionMar 5, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL DIALYZER BLOOD LEAK OCCURRED DURING A PATIENT'S HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK OCCURRED APPROXIMATELY TWENTY MINUTES INTO THE TREATMENT. BLOOD WAS OBSERVED TO BE LEAKING FROM THE JOINT LOCATED AT THE END OF THE DIALYZER. THERE WAS NO VISIBLE DAMAGE OR DEFECT NOTED AT THE LEAK LOCATION. THERE WERE NO ALARMS FROM THE MACHINE, A FRESENIUS 5008. UPON DETECTION OF THE LEAK, THE TREATMENT WAS STOPPED. THE PATIENT'S BLOOD WAS NOT RETURNED; ESTIMATED BLOOD LOSS (EBL) WAS 150 ML. THERE WAS NO INDICATION THAT THE PATIENT EXPERIENCED A SERIOUS INJURY OR REQUIRED MEDICAL INTERVENTION DUE TO THE BLOOD LOSS. THE PATIENT COMPLETED THEIR TREATMENT AFTER BEING RE-SETUP WITH NEW SUPPLIES ON THE SAME MACHINE. THE SAMPLE WAS CONFIRMED TO BE AVAILABLE TO BE RETURNED FOR MANUFACTURER EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24524734 ↗
• MalfunctionFeb 18, 2026Fluid/Blood Leak

  A USER FACILITY INVENTORY MANAGER REPORTED THAT A DIALYZER BLOOD LEAK OCCURRED DURING THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP WITH A FACILITY REGISTERED NURSE (RN). THE REPORTED ISSUE OCCURRED IMMEDIATELY AFTER THE INITIATION OF TREATMENT. THE BLOOD LEAK WAS NOTED AS BEING AN INTERNAL BLOOD LEAK. THE LEAK WAS VISUALLY OBSERVED WITHIN THE DIALYZER. THE FRESENIUS 2008K2 MACHINE ALARMED APPROPRIATELY WITH A BLOOD LEAK ALARM. BLOOD LEAK TEST STRIPS WERE NOT USED TO TEST FOR THE PRESENCE OF BLOOD. THERE WAS NO DEFECT OR DAMAGE NOTED ON THE DIALYZER. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 250 ML. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT WAS RESTARTED ON A NEW MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THE COMPLAINT DEVICE WAS REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24377226 ↗
• MalfunctionFeb 17, 2026Fluid/Blood Leak

  A USER FACILITY REPORTED TO FMC CANADA (FMCC) THAT A VISIBLE EXTERNAL DIALYZER BLOOD LEAK OCCURRED ONE HOUR AND TWENTY-FIVE MINUTES AFTER THE INITIATION OF A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE MACHINE, A FRESENIUS 5008 MACHINE, ALARMED APPROPRIATELY WITH A BLOOD LEAK ALARM. THE LEAK WAS NOTED ON THE SEAM OF THE DIALYZER ON THE VENOUS END. FRESENIUS BLOODLINES WERE ALSO IN USE. THE PATIENT¿S BLOOD WAS COMPLETELY RETURNED FOLLOWING THE INCIDENT. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) IS UNKNOWN. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED DUE TO THIS EVENT. THE PATIENT WAS RESTARTED ON THE SAME MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24364708 ↗
• MalfunctionJan 14, 2026Fluid/Blood Leak

  A CORPORATE INVENTORY MANAGER REPORTED TO FRESENIUS THAT A DIALYZER BLOOD LEAK OCCURRED AT A HEMODIALYSIS (HD) USER FACILITY. ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOW-UP WITH A REGISTERED NURSE (RN) FROM THE FACILITY. THE RN STATED THE BLOOD LEAK OCCURRED IMMEDIATELY AT THE START OF HD TREATMENT. THE BLOOD LEAK WAS INTERNAL, AND IT WAS CONFIRMED TO BE VISUALLY OBSERVED. THE MACHINE, A FRESENIUS 2008T MACHINE, ALARMED APPROPRIATELY WITH A BLOOD LEAK ALARM. A BLOOD LEAK TEST STRIP WAS USED, AND IT TESTED POSITIVE FOR THE PRESENCE OF BLOOD. THERE WAS NO DAMAGE OR DEFECT NOTED ON THE DIALYZER. FRESENIUS BLOODLINES WERE ALSO BEING USED. AFTER THE LEAK OCCURRED, THE TREATMENT WAS PAUSED. THE PATIENT¿S BLOOD WAS NOT RETURNED; ESTIMATED BLOOD LOSS (EBL) WAS LESS THAN 100 ML. THE RN CONFIRMED THERE WAS NO PATIENT SERIOUS INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. THE PATIENT COMPLETED THEIR TREATMENT AFTER BEING RE-SETUP WITH NEW SUPPLIES ON A DIFFERENT MACHINE. THE SAMPLE WAS NOT AVAILABLE TO BE RETURNED FOR MANUFACTURER EVALUATION AS IT WAS REPORTEDLY DISCARDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24073152 ↗
• MalfunctionJan 8, 2026Fluid/Blood Leak

  A USER FACILITY CLINICAL MANAGER REPORTED THAT A VISIBLE EXTERNAL DIALYZER BLOOD LEAK OCCURRED FORTY-FIVE MINUTES AFTER THE INITIATION OF THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE MACHINE, A FRESENIUS 2008T MACHINE, DID NOT ALARM, BUT IS NOT EXPECTED TO FOR AN EXTERNAL BLOOD LEAK. A CRACK WAS NOTED ON THE DIALYZER. FRESENIUS BLOODLINES WERE NOT IN USE. THE PATIENT¿S BLOOD WAS COMPLETELY RETURNED FOLLOWING THE INCIDENT. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) IS UNKNOWN. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT WAS RESTARTED ON THE SAME MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24003239 ↗
• MalfunctionJan 8, 2026Fluid/Blood Leak

  A USER FACILITY CLINICAL MANAGER REPORTED THAT A VISIBLE EXTERNAL DIALYZER BLOOD LEAK OCCURRED THIRTY MINUTES AFTER THE INITIATION OF THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE MACHINE, A FRESENIUS 2008T MACHINE, DID NOT ALARM, BUT IS NOT EXPECTED TO FOR AN EXTERNAL BLOOD LEAK. A CRACK WAS NOTED ON THE DIALYZER. FRESENIUS BLOODLINES WERE NOT IN USE. THE PATIENT¿S BLOOD WAS COMPLETELY RETURNED FOLLOWING THE INCIDENT. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) IS 100ML. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT WAS RESTARTED ON THE SAME MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24003238 ↗
• MalfunctionJan 8, 2026Fluid/Blood Leak

  A USER FACILITY OFFICE MANAGER REPORTED THAT A VISIBLE EXTERNAL DIALYZER BLOOD LEAK OCCURRED ONE HOUR AFTER THE INITIATION OF THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE MACHINE, A FRESENIUS 2008T MACHINE, DID NOT ALARM, BUT IS NOT EXPECTED TO FOR AN EXTERNAL BLOOD LEAK. A CRACK WAS NOTED ON THE DIALYZER. FRESENIUS BLOODLINES WERE NOT IN USE. THE PATIENT¿S BLOOD WAS COMPLETELY RETURNED FOLLOWING THE INCIDENT. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) IS UNKNOWN. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT WAS RESTARTED ON THE SAME MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24003093 ↗
• MalfunctionJan 8, 2026Fluid/Blood Leak

  A USER FACILITY OFFICE MANAGER REPORTED THAT A VISIBLE EXTERNAL DIALYZER BLOOD LEAK OCCURRED THIRTY MINUTES AFTER THE INITIATION OF THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE MACHINE, A FRESENIUS 2008T MACHINE, DID NOT ALARM, BUT IS NOT EXPECTED TO FOR AN EXTERNAL BLOOD LEAK. A CRACK WAS NOTED ON THE DIALYZER. FRESENIUS BLOODLINES WERE NOT IN USE. THE PATIENT¿S BLOOD WAS COMPLETELY RETURNED FOLLOWING THE INCIDENT. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) IS UNKNOWN. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT WAS RESTARTED ON THE SAME MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24003025 ↗
• MalfunctionJan 8, 2026Fluid/Blood Leak

  A USER FACILITY OFFICE MANAGER REPORTED THAT A VISIBLE EXTERNAL DIALYZER BLOOD LEAK OCCURRED THIRTY MINUTES AFTER THE INITIATION OF THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE MACHINE, A FRESENIUS 2008T MACHINE, DID NOT ALARM, BUT IS NOT EXPECTED TO FOR AN EXTERNAL BLOOD LEAK. A CRACK WAS NOTED ON THE DIALYZER. FRESENIUS BLOODLINES WERE NOT IN USE. THE PATIENT¿S BLOOD WAS COMPLETELY RETURNED FOLLOWING THE INCIDENT. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) IS 100ML. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT WAS RESTARTED ON THE SAME MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24002948 ↗
• MalfunctionJan 8, 2026Fluid/Blood Leak

  A USER FACILITY CLINICAL MANAGER REPORTED THAT A VISIBLE EXTERNAL DIALYZER BLOOD LEAK OCCURRED THIRTY MINUTES AFTER THE INITIATION OF THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE MACHINE, A FRESENIUS 2008T MACHINE, DID NOT ALARM, BUT IS NOT EXPECTED TO FOR AN EXTERNAL BLOOD LEAK. A CRACK WAS NOTED ON THE DIALYZER. FRESENIUS BLOODLINES WERE NOT IN USE. THE PATIENT¿S BLOOD WAS COMPLETELY RETURNED FOLLOWING THE INCIDENT. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) IS 100ML. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT WAS RESTARTED ON THE SAME MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24002876 ↗
• MalfunctionJan 8, 2026Fluid/Blood Leak

  A USER FACILITY OFFICE MANAGER REPORTED THAT A VISIBLE EXTERNAL DIALYZER BLOOD LEAK OCCURRED FORTY MINUTES AFTER THE INITIATION OF THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE MACHINE, A FRESENIUS 2008T MACHINE, DID NOT ALARM, BUT IS NOT EXPECTED TO FOR AN EXTERNAL BLOOD LEAK. A CRACK WAS NOTED ON THE DIALYZER. FRESENIUS BLOODLINES WERE NOT IN USE. THE PATIENT¿S BLOOD WAS COMPLETELY RETURNED FOLLOWING THE INCIDENT. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) IS UNKNOWN. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT WAS RESTARTED ON THE SAME MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24002746 ↗
• MalfunctionJan 8, 2026Fluid/Blood Leak

  A USER FACILITY CLINICAL MANAGER REPORTED THAT A VISIBLE EXTERNAL DIALYZER BLOOD LEAK OCCURRED ONE HOUR AFTER THE INITIATION OF THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE MACHINE, A FRESENIUS 2008T MACHINE, DID NOT ALARM, BUT IS NOT EXPECTED TO FOR AN EXTERNAL BLOOD LEAK. A CRACK WAS NOTED ON THE DIALYZER. FRESENIUS BLOODLINES WERE NOT IN USE. THE PATIENT¿S BLOOD WAS COMPLETELY RETURNED FOLLOWING THE INCIDENT. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) IS 100ML. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT WAS RESTARTED ON THE SAME MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. ONE PHOTOGRAPH HAS BEEN PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24002701 ↗