Optiflux® 0500320ERecalls & reported problems

Summary

The FDA's MAUDE database contains 242 adverse event reports that list this exact device (DI 00840861100163), received between Jul 11, 2017 and Sep 22, 2026 — classified as 9 injuries, 233 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (238 reports).

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. 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 ↗

2. May 4, 2022Terminated

   Dialyzers were distributed after being exposed to cold temperatures which exceeded the low-temperature range in the firm's standard operating procedure.

   Z-1303-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 242 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Fluid/Blood Leak

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50858828 ↗
• MalfunctionSep 17, 2026Fluid/Blood Leak

  an internal dialyzer blood leak occurred with forty-five minutes remaining in a patient¿s hemodialysis (HD) treatment. The leak was not visibly observed. The machine, a FME 2008T machine, alarmed appropriately with a blood leak alarm. Blood leak test strips were used and tested positive for the presence of blood. A FME bloodline was in use. There was no obvious defect or damage seen on the dialyzer. The patient¿s estimated blood loss (EBL) is 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 not available to be returned to the manufacturer for evaluation.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50804278 ↗
• MalfunctionSep 17, 2026Fluid/Blood Leak

  A user facility¿s biomedical technician (BMT) reported that a visible internal dialyzer blood leak occurred eighteen minutes after the initiation of a patient¿s hemodialysis (HD) treatment. The machine, a FME 2008T machine, alarmed appropriately with a blood leak alarm. Blood leak test strips were used and tested positive for the presence of blood. 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, but the estimated blood loss (EBL) is unknown. 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.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50803790 ↗
• MalfunctionAug 31, 2026Fluid/Blood Leak

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50530767 ↗
• MalfunctionMay 19, 2026Fluid/Blood Leak

  A SUPPLIES MANAGER REPORTED A DIALYZER BLOOD LEAK ASSOCIATED WITH A HEMODIALYSIS (HD) TREATMENT. IN A FOLLOW UP, A NURSE SAID THE LEAK OCCURRED IMMEDIATELY AT STARTING THE HEMODIALYSIS (HD) TREATMENT.THE NURSE EXPLAINED THAT THE LEAK WAS VISUALLY SEEN AS BLOOD WAS DRIPPING FROM THE SIDE OF THE DIALYZER ON THE FLOOR FROM THE TOP SEAL OF THE DIALYZER. THE BLOOD LEAK WAS DESCRIBED AS BEING AN EXTERNAL BLOOD LEAK. A FRESENIUS 2008K MACHINE WAS BEING.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 250CC. 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 AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25221261 ↗
• MalfunctionApr 8, 2026Fluid/Blood Leak

  IT WAS REPORTED TO FRESENIUS THAT A DIALYZER BLOOD LEAK OCCURRED DURING THE PATIENT'S HEMODIALYSIS (HD) TREATMENT. TREATMENT WAS STARTED AND IT WAS NOTED THAT THE DIALYZER HEAD WAS LEAKING BLOOD. TREATMENT WAS STOPPED. THE PATIENT'S BLOOD WAS NOT RETURNED. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 250 ML. TREATMENT RESUMED WITH A NEW DIALYSIS SETUP. THE PATIENT WAS MONITORED DURING TREATMENT. NO SERIOUS INJURY OR REQUIRED MEDICAL INTERVENTION WAS REPORTED. NO SAMPLES WERE REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. NO ADDITIONAL INFORMATION WAS OBTAINED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24815775 ↗
• MalfunctionApr 3, 2026Fluid/Blood Leak

  A USER FACILITY REPORTED TO FRESENIUS MEDICAL CARE CANADA THAT A BLOOD LEAK OCCURRED TWO HOURS AND FIFTY-TWO MINUTES AFTER THE INITIATION OF THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. IT WAS NOT CLEAR IF THE LEAK ORIGINATED FROM THE DIALYZER OR THE BLOODLINE. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) IS UNKNOWN. THE COMPLAINT DEVICE IS NOT 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 INFORMATION HAS BEEN PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24778376 ↗
• MalfunctionApr 1, 2026Fluid/Blood Leak

  THE REGISTERED NURSE (RN) REPORTED TO FRESENIUS THAT A DIALYZER BLOOD LEAK OCCURRED DURING THE PATIENT'S HEMODIALYSIS (HD) TREATMENT. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP WITH THE CLINICAL MANAGER (CM). THE REPORTED ISSUE OCCURRED UPON TREATMENT INITIATION. THE FRESENIUS 2008T MACHINE ALARMED AS EXPECTED WITH A BLOOD LEAK ALARM. BLOOD LEAK TEST STRIPS WERE NOT USED TO TEST FOR THE PRESENCE OF BLOOD. THE PATIENT CARE TECHNICIAN (PCT) VISUALLY OBSERVED PINK DIALYSATE AND IMMEDIATELY CLAMPED THE VENOUS AND ARTERIAL LINES. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) IS APPROXIMATELY 250 ML. NO SERIOUS INJURY OR REQUIRED MEDICAL INTERVENTION RESULTED FROM THE REPORTED ISSUE. THE PATIENT WAS RESTARTED ON A NEW MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THE COMPLAINT DEVICE WAS REPORTED TO BE DISCARDED AND UNAVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24756129 ↗
• MalfunctionMar 30, 2026Fluid/Blood Leak

  A USER FACILITY REPORTED TO FRESENIUS MEDICAL CARE CANADA (FMCC) THAT AN EXTERNAL DIALYZER BLOOD LEAK OCCURRED TEN MINUTES AFTER THE INITIATION OF THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE MACHINE, A FRESENIUS 5008 MACHINE, DID NOT ALARM BUT WAS NOT EXPECTED TO. A FRESENIUS BLOODLINE WAS ALSO IN USE. BLOOD LEAK TEST STRIPS WERE USED AND TESTED POSITIVE FOR THE PRESENCE OF BLOOD. THERE WAS NO DEFECT OR DAMAGE NOTED ON THE DIALYZER. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 420ML. THE PATIENT WAS RESTARTED ON THE SAME MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED DUE TO THIS EVENT. THE COMPLAINT DEVICE WAS REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24714959 ↗
• MalfunctionMar 26, 2026Fluid/Blood Leak

  A USER FACILITY REPORTED TO FRESENIUS MEDICAL CARE CANADA THAT AN EXTERNAL DIALYZER BLOOD LEAK OCCURRED TWO HOURS AND FIFTY-TWO MINUTES AFTER THE INITIATION OF THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. A FRESENIUS BLOODLINE AND HD MACHINE WERE ALSO IN USE. THERE WAS NO DEFECT OR DAMAGE NOTED ON THE DIALYZER. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 50ML. THE PATIENT WAS RESTARTED ON A NEW MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED DUE TO THIS EVENT. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24701601 ↗
• InjuryMar 12, 2026Fluid/Blood Leak

  ON (B)(6) 2026, FRESENIUS BECAME AWARE THIS 81-YEAR-OLD FEMALE PATIENT WITH END STAGE RENAL DISEASE (ESRD) ON HEMODIALYSIS (HD) SINCE 2021 FOR RENAL REPLACEMENT THERAPY (RRT) EXPERIENCED AN OPTIFLUX 200NRE DIALYZER BLOOD LEAK DURING HD THERAPY ON (B)(6) 2026. THE DESCRIPTION OF THE EVENT REVEALED THAT AFTER APPROXIMATELY 2 HOURS AND 20 MINUTES INTO TREATMENT, THE PATIENT EXPERIENCED AN OPTIFLUX 200NRE DIALYZER BLOOD LEAK. ALTHOUGH THE EVIDENCE OF THE BLOOD LEAK WAS VISIBLE ON THE FLOOR, THE HANSON CONNECTORS, AND THE 5008 HEMODIALYSIS SYSTEM ITSELF, NO VISIBLE DEFECT WAS NOTED. ACCORDING TO THE REPORT, THE BLOOD LEAK OCCURRED ¿AT THE SEAL BETWEEN THE FLAT END OF THE DIALYZER AND THE CYLINDRICAL PART.¿ ONCE DISCOVERED THE TREATMENT WAS DISCONTINUED, AND THE PATIENT¿S EXTRACORPOREAL BLOOD WAS DISCARDED (ESTIMATED BLOOD LOSS = 310-360 ML). ALTHOUGH THE DEFINITIVE TIMELINE IS UNKNOWN, IT APPEARS THE PATIENT BECAME HYPOTENSIVE FOLLOWING THE BLOOD LOSS EVENT AND SUSTAINED A FALL TO THE FLOOR. THE PATIENT RECEIVED A 200 ML BOLUS OF NORMAL SALINE, HD WAS RESTARTED WITH NEW SUPPLIES, AND THE TREATMENT WAS COMPLETED WITHOUT ANY REPORTED ISSUES. THERE WAS NO REPORT OF INJURY FROM THE PATIENT¿

  Patient problems: Fall; Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension

  MAUDE report 24580762 ↗
• MalfunctionMar 11, 2026Fluid/Blood Leak

  A USER FACILITY¿S REGISTERED NURSE (RN) REPORTED THAT AN EXTERNAL DIALYZER BLOOD LEAK OCCURRED THIRTEEN MINUTES AFTER THE INITIATION OF A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE LEAK ORIGINATED FROM THE HEAD OF THE DIALYZER. THE MACHINE, A FRESENIUS 2008T MACHINE, DID NOT ALARM, BUT WAS NOT EXPECTED TO. A FRESENIUS BLOODLINE WAS ALSO IN USE. BLOOD LEAK TEST STRIPS WERE USED AND TESTED NEGATIVE FOR THE PRESENCE OF BLOOD, SO THE PATIENT¿S BLOOD WAS RETURNED. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 50ML. THE PATIENT WAS RESTARTED ON THE SAME MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE COMPLAINT DEVICE WAS REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. A PHOTO HAS BEEN PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24571579 ↗
• MalfunctionMar 11, 2026Fluid/Blood Leak

  A USER FACILITY¿S CLINICAL MANAGER REPORTED THAT AN INTERNAL DIALYZER BLOOD LEAK OCCURRED TWENTY MINUTES AFTER THE INITIATION OF THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE LEAK WAS NOT VISUALLY OBSERVED. THE MACHINE, A FRESENIUS 2008T MACHINE, ALARMED APPROPRIATELY WITH A BLOOD LEAK ALARM. A FRESENIUS BLOODLINE WAS NOT IN USE. BLOOD LEAK TEST STRIPS WERE USED AND TESTED POSITIVE FOR THE PRESENCE OF BLOOD. THERE WAS NO DEFECT OR DAMAGE NOTED ON THE DIALYZER. THE PATIENT¿S BLOOD WAS COMPLETELY RINSED BACK. NO BLOOD WAS LOST. THE PATIENT RESTARTED ON A NEW MACHINE WITH A NEW SET UP. TEN MINUTES AFTER THE INITIATION OF THAT TREATMENT, ANOTHER INTERNAL DIALYZER BLOOD LEAK OCCURRED. THE LEAK WAS NOT VISUALLY OBSERVED. THE MACHINE, A FRESENIUS 2008T MACHINE, ALARMED APPROPRIATELY WITH A BLOOD LEAK ALARM. A FRESENIUS BLOODLINE WAS NOT IN USE. BLOOD LEAK TEST STRIPS WERE USED AND TESTED POSITIVE FOR THE PRESENCE OF BLOOD. THERE WAS NO DEFECT OR DAMAGE NOTED ON THE DIALYZER. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS 100ML. THE PATIENT WAS RESTARTED ON A NEW MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUI

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24569656 ↗
• MalfunctionMar 10, 2026Fluid/Blood Leak

  A USER FACILITY REGISTERED NURSE (RN) REPORTED THAT A DIALYZER BLOOD LEAK OCCURRED AT THE INITIATION OF A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK WAS REPORTED TO BE INTERNAL, AND BLOOD WAS CONFIRMED TO BE VISUALLY OBSERVED OUTSIDE OF THE FIBERS. THE MACHINE, A FRESENIUS 2008T MACHINE, DID NOT ALARM WITH A BLOOD LEAK ALERT. THE RN EXPLAINED THAT THE MACHINE ALARM DID NOT GO OFF BECAUSE OF HOW QUICKLY THE BLOOD LEAK WAS CAUGHT. THE BLOOD PUMP WAS STOPPED IMMEDIATELY AFTER THEY NOTICED. A BLOOD LEAK TEST STRIP WAS NOT USED AS IT WAS DEEMED UNNECESSARY. THERE WAS NO DAMAGE OR DEFECT NOTED ON THE DIALYZER. FRESENIUS BLOODLINES WERE ALSO BEING USED. THE PATIENT¿S BLOOD WAS NOT RETURNED. THE RN SAID THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS 250 TO 300 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 THE SAME MACHINE. THE SAMPLE WAS CONFIRMED TO BE AVAILABLE TO BE RETURNED FOR MANUFACTURER EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24562501 ↗
• MalfunctionFeb 26, 2026Fluid/Blood Leak

  THE FACILITY ADMINISTRATOR (FA) REPORTED TO FRESENIUS THAT A DIALYZER BLOOD LEAK OCCURRED DURING THE PATIENT'S HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK OCCURRED APPROXIMATELY 1 HOUR AND 22 MINUTES PRIOR TO THE COMPLETION OF THE PATIENT'S 4-HOUR TREATMENT. THE BLOOD LEAK WAS INTERNAL. THE BLOOD LEAK COULD NOT BE VISUALLY OBSERVED. THE FRESENIUS 2008T MACHINE ALARMED APPROPRIATELY WITH A BLOOD LEAK ALARM. BLOOD LEAK TEST STRIPS WERE USED AND TESTED POSITIVE FOR THE PRESENCE OF BLOOD. NO DEFECT OR DAMAGE WAS NOTED TO THE DIALYZER. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 100 ML. NO SERIOUS INJURY OR REQUIRED MEDICAL INTERVENTION RESULTED FROM THE REPORTED ISSUE. THE PATIENT OPTED TO END TREATMENT FOR THE DAY. THE DIALYZER WAS REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24454659 ↗
• MalfunctionFeb 19, 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 WHO WAS FAMILIAR WITH THE EVENT. THE BLOOD LEAK, WHICH WAS EXTERNAL, WAS NOTICED APPROXIMATELY ONE HOUR INTO A PATIENT¿S HD TREATMENT. A TECHNICIAN NOTICED BLOOD LEAKING FROM THE ARTERIAL HEADER OF THE DEVICE WHILE PASSING BY. THERE WERE NO ALARMS FROM THE MACHINE. THERE WAS NO VISIBLE DAMAGE OR DEFECT NOTED ON THE DIALYZER, INCLUDING AT/NEAR THE LEAK LOCATION. AFTER THE LEAK WAS NOTICED, THE TREATMENT WAS PAUSED. THE PATIENT¿S BLOOD WAS NOT RETURNED; ESTIMATED BLOOD LOSS (EBL) WAS 250 TO 300 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 THE SAME 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 24394720 ↗
• MalfunctionFeb 11, 2026Fluid/Blood Leak

  A USER FACILITY REPORTED TO FMC CANADA (FMCC) THAT A VISIBLE EXTERNAL DIALYZER BLOOD LEAK OCCURRED DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) IS UNKNOWN. THERE WAS NO MEDICAL INTERVENTION REQUIRED DUE TO THIS EVENT. IT IS UNKNOWN IF 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.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24314756 ↗
• MalfunctionFeb 5, 2026Fluid/Blood Leak

  A USER FACILITY REGISTERED NURSE (RN) REPORTED THAT A DIALYZER LEAK OCCURRED APPROXIMATELY FIVE MINUTES AFTER THE INITIATION OF A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. ADDITIONAL DETAILS WERE PROVIDED UPON FOLLOW-UP WITH THE FACILITY¿S CLINICAL MANAGER (CM). THE BLOOD LEAK WAS REPORTED TO BE EXTERNAL. THERE WAS A VISIBLE CRACK NEAR THE HEAD OF THE DIALYZER. THE MACHINE, A FRESENIUS 2008T MACHINE, DID NOT ALARM. THE PATIENT DID NOT EXPERIENCE ANY BLOOD LOSS. THE CM STATED IT WAS ONLY DIALYSATE THAT LEAKED OUTSIDE OF THE DIALYZER. SINCE IT WAS EARLY IN THE TREATMENT, THE CM SAID THE DIALYZER WAS NOT FILLED WITH BLOOD. THERE WAS NO PATIENT SERIOUS INJURY, NOR WAS MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS 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. NO PHOTOS WERE AVAILABLE FOR REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24272907 ↗
• MalfunctionFeb 4, 2026Fluid/Blood Leak

  A USER FACILITY REPORTED THAT A DIALYZER BLOOD LEAK OCCURRED APPROXIMATELY FIVE MINUTES AFTER THE INITIATION OF THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK WAS NOTED AS BEING AN INTERNAL BLOOD LEAK. THE LEAK WAS VISUALLY OBSERVED INSIDE THE DIALYZER. THE MACHINE, A FRESENIUS 2008T MACHINE, ALARMED APPROPRIATELY WITH A BLOOD LEAK ALARM. BLOOD LEAK TEST STRIPS WERE USED AND TESTED NEGATIVE FOR THE PRESENCE OF BLOOD. THERE WAS NO DEFECT OR DAMAGE NOTED ON THE DIALYZER. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 100 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 24260223 ↗
• MalfunctionJan 16, 2026Fluid/Blood Leak

  A USER FACILITY¿S INVENTORY MANAGER REPORTED THAT A DIALYZER BLOOD LEAK OCCURRED DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) IS UNKNOWN. IT IS UNKNOWN IF 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 INFORMATION HAS BEEN PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE FILE WILL BE UPDATED ACCORDINGLY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24094950 ↗
• MalfunctionJan 14, 2026Fluid/Blood Leak

  A USER FACILITY'S PURCHASING DIRECTOR REPORTED THAT AN EXTERNAL DIALYZER FLUID LEAK OCCURRED. THE LEAK ORIGINATED FROM HOLES NEAR THE HEADER OF THE DIALYZER. IT IS UNKNOWN IF THERE WAS ANY BLOOD LOSS, PATIENT SERIOUS INJURY OR ADVERSE EVENT. IT IS UNKNOWN IF THE COMPLAINT DEVICE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. TWO PHOTOGRAPHS HAVE BEEN PROVIDED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO CONTACT THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE REPORTED EVENT. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24069402 ↗
• MalfunctionJan 12, 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 USER FACILITY NURSE. THE REPORTED ISSUE OCCURRED UPON TREATMENT INITIATION. THE BLOOD LEAK WAS NOTED AS BEING AN INTERNAL BLOOD LEAK. THE LEAK WAS VISUALLY OBSERVED WITHIN THE DIALYZER. THE MACHINE, A FRESENIUS 2008K2 MACHINE, ALARMED APPROPRIATELY WITH A BLOOD LEAK ALARM. THERE WAS NO DEFECT OR DAMAGE NOTED ON THE DIALYZER. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS DEFINED AS "LESS THAN 500 ML." THERE WAS NO PATIENT 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 WAS REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24035745 ↗
• MalfunctionJan 9, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL DIALYZER BLOOD LEAK OCCURRED APPROXIMATELY ONE HOUR AND THIRTY MINUTES AFTER THE START OF A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE ATTENDING NURSE NOTICED A POOL OF BLOOD ON THE FLOOR. THE BLOOD LEAK APPEARED TO ORIGINATE FROM THE ARTERIAL BASE OF THE DIALYZER (BETWEEN THE CYLINDRICAL PORTION AND THE FLAT SURFACE WHERE THE SEAL IS LOCATED). NO MACHINE ALARM OCCURRED. OBSERVABLE DAMAGE WAS NOTED ON THE DIALYZER; A PHOTO WAS PROVIDED AS EVIDENCE. DURING THE PRIMING PHASE, THERE WAS NO LEAKAGE OBSERVED ON THE FLOOR. THE PATIENT¿S BLOOD WAS NOT RETURNED. TOTAL BLOOD LOSS WAS ESTIMATED TO BE 320CC TO 340CC. THE EXTRACORPOREAL CIRCUIT HAD TO BE DISCARDED, RESULTING IN BLOOD LOSS OF APPROXIMATELY 300CC, AND APPROXIMATELY 20 TO 40CC OF BLOOD LEAKED ONTO THE FLOOR. THE PHYSICIAN HAD TO BE CONTACTED, AND INTRAVENOUS ANTIBIOTICS WERE ADMINISTERED POST-DIALYSIS, ALONG WITH FOLLOW-UP BLOOD TESTS AT THE SUBSEQUENT DIALYSIS SESSION. IT WAS CONFIRMED THAT THE ANTIBIOTICS WERE ADMINISTERED AS A PROPHYLACTIC MEASURE. THERE WERE NO REPORTS OF A SERIOUS PATIENT INJURY OR ANY ADVERSE EFFECTS. THE PATIENT WAS ABLE TO COMPLETE THEIR TREATMENT AFTER BEING RE-SETUP WITH

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24024446 ↗
• MalfunctionDec 23, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A CLINICAL CARE ADVISOR REPORTED TO FRESENIUS THAT A DIALYZER BLOOD LEAK OCCURRED DURING THE PATIENT'S TREATMENT. THE REPORTED ISSUE OCCURRED APPROXIMATELY 10 MINUTES AFTER TREATMENT INITIATION ON THE FRESENIUS 5008 MACHINE. THE BLOOD LEAK WAS EXTERNAL. THE NURSE VISUALLY OBSERVED BLOOD STREAKING ALONG THE ENTIRE LENGTH OF THE DIALYZER ORIGINATING FROM THE ARTERIAL CAP. THE ARTERIAL BLOOD INLET TUBING WAS INTACT. POSSIBLE CRACKS AT THE LEVEL OF THE CAP WERE SUSPECTED. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 300 ML. NO SERIOUS INJURY OR REQUIRED MEDICAL INTERVENTION RESULTED FROM THE REPORTED ISSUE. IT WAS STATED THE BLOODLINES WERE DISCARDED AND TREATMENT CONTINUED ON A DIFFERENT MACHINE. THE SAMPLE WAS NOT REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23877041 ↗
• MalfunctionDec 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A HOSPITAL REPORT WAS RECEIVED FROM HEALTH CANADA REPORTING THAT A FRESENIUS OPTIFLUX DIALYZER EXPERIENCED AN INTERNAL DIALYZER BLOOD LEAK OCCURRED FIVE MINUTES AFTER THE INITIATION OF THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE LEAK WAS NOT VISUALLY OBSERVED. THE MACHINE AND BLOODLINES WERE NOT FRESENIUS PRODUCTS. BLOOD LEAK TEST STRIPS WERE USED AND TESTED NEGATIVE FOR THE PRESENCE OF BLOOD. THERE WAS NO DEFECT OR DAMAGE NOTED ON THE DIALYZER. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 200ML. THERE WAS NO PATIENT SERIOUS 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 IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23768304 ↗