Optiflux® 0500306ERecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00840861100071), received between Jul 24, 2018 and Aug 6, 2021 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (12 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2021Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY NURSE REPORTED THAT AN INTERNAL DIALYZER BLOOD LEAK OCCURRED DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. IT WAS REPORTED THAT THE BLOOD WAS OBSERVED IN THE VENOUS HEARD CAP OF THE DIALYZER. THE NURSING STAFF WAS ABLE TO DETECT THE LEAK. THE MACHINE, A FRESENIUS 4008'S, ALARMED APPROPRIATELY WITH A BLOOD LEAK ALERT. FRESENIUS COMBI SET BLOODLINES WERE BEING UTILIZED FOR THE TREATMENT. BLOOD TEST STRIPS WERE NOT USED. NO DAMAGE WAS IDENTIFIED ON THE DIALYZER PRIOR TO USE. IMMEDIATELY FOLLOWING THE EVENT, THE PATIENT WAS RE-SETUP WITH NEW SUPPLIES ON A DIFFERENT MACHINE WHERE THEY WERE ABLE TO COMPLETE TREATMENT. DESPITE THE BLOOD LEAK, IT WAS REPORTED THAT THERE WAS NO BLOOD LOSS AS THE BLOOD WAS RETURNED TO THE PATIENT. IT WAS CONFIRMED THERE WAS NO PATIENT INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. THE DIALYZER WAS NOT AVAILABLE TO BE RETURNED FOR A MANUFACTURER EVALUATION AS IT WAS REPORTEDLY DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12291421 ↗
• MalfunctionAug 11, 2020Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY NURSE REPORTED THAT AN INTERNAL DIALYZER BLOOD LEAK OCCURRED APPROXIMATELY ONE MINUTE INTO A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. BLOOD WAS VISUALLY OBSERVED ON THE OUTSIDE OF THE DIALYZER FILTER. THE MACHINE, A FRESENIUS 4008S, ALARMED WITH A BLOOD LEAK ALERT. FRESENIUS COMBI SET BLOODLINES WERE BEING UTILIZED FOR THE TREATMENT. BLOOD TEST STRIPS WERE NOT USED. NO DEFECTS WERE IDENTIFIED ON THE DIALYZER PRIOR TO USE. HOWEVER, AFTER THE BLOOD LEAK OCCURRED, BROKEN FIBER MEMBRANES WERE IDENTIFIED. THE TREATMENT WAS IMMEDIATELY STOPPED FOLLOWING THE EVENT. THE PATIENT COMPLETED THEIR TREATMENT AFTER BEING RE-SETUP WITH NEW SUPPLIES ON A DIFFERENT MACHINE. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 50 ML. IT WAS CONFIRMED THERE WAS NO PATIENT INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. THE DIALYZER WAS NOT AVAILABLE TO BE RETURNED FOR A MANUFACTURER EVALUATION AS IT WAS REPORTEDLY DISCARDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10391743 ↗
• MalfunctionMay 26, 2020Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION WAS RECEIVED: UPON FOLLOW-UP, THE USER FACILITY CONTACT STATED THAT A FRESENIUS 2000K2 MACHINE WAS BEING USED DURING THE EVENT. BLOOD TEST STRIPS WERE USED AND TESTED POSITIVE FOR THE PRESENCE OF BLOOD. IT WAS REPORTED THE LEAK WAS INTERNAL AND THERE WAS NO DEFECT OR DAMAGE NOTED ON THE DIALYZER. ALTHOUGH IT WAS ORIGINALLY UNKNOWN IF THE PATIENT LOST BLOOD, IT WAS CONFIRMED THERE WAS NO BLOOD LOSS AS THE PATIENT'S BLOOD WAS RINSED BACK SUCCESSFULLY. THERE WAS NO PATIENT INJURY, ADVERSE EVENT, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED EVENT. THE PATIENT WAS ABLE TO COMPLETE TREATMENT WITH A NEW SETUP ON THE SAME MACHINE. THE DIALYZER WAS REPORTED TO BE AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10089793 ↗
• MalfunctionMay 5, 2020Fluid/Blood Leak; Fluid/Blood Leak

  A DIALYSIS LAB MANAGER REPORTED THAT AN INTERNAL DIALYZER BLOOD LEAK OCCURRED APPROXIMATELY THIRTY MINUTES INTO A PATIENT'S HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK WAS VISUALLY OBSERVED IN THE DIALYSATE LINES AND IN THE DIALYSATE COMPARTMENT OF THE DEVICE. THE MACHINE, A FRESENIUS 2008T, ALARMED APPROPRIATELY WITH A BLOOD LEAK ALERT. A BLOOD LEAK TEST STRIP WAS USED TO TEST FOR THE PRESENCE OF BLOOD, AND IT TESTED POSITIVE. MEDISYSTEMS BLOODLINES WERE USED FOR THE TREATMENT. THERE WAS NO REPORTED DAMAGE IDENTIFIED ON THE DIALYZER. AFTER THE MACHINE ALARMED, THE TREATMENT WAS HALTED. THE PATIENT¿S BLOOD WAS NOT RETURNED; ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 200 ML. THE LAB MANAGER CONFIRMED THERE WAS NO PATIENT INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. THE PATIENT WAS ABLE TO COMPLETE TREATMENT AFTER BEING RE-SETUP WITH NEW SUPPLIES ON A DIFFERENT MACHINE. THE SAMPLE WAS REPORTEDLY SENT BACK FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10025376 ↗
• MalfunctionMar 27, 2020Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY BIOMEDICAL TECHNICIAN REPORTED A DIALYZER BLOOD LEAK THAT OCCURRED DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. FOLLOW UP REVEALED THAT THE BLOOD LEAK OCCURRED LESS THAN THIRTY MINUTES INTO THE TREATMENT, AND THE LEAK WAS REPORTED TO BE INTERNAL. THE BLOOD LEAK WAS VISUALLY OBSERVED IN THE DIALYSATE LINES AND IN THE DIALYSATE COMPARTMENT OF THE DEVICE. THE MACHINE, A FRESENIUS 2008T, ALARMED APPROPRIATELY WITH A BLOOD LEAK ALERT. A BLOOD LEAK TEST STRIP WAS USED TO TEST FOR THE PRESENCE OF BLOOD, AND IT TESTED POSITIVE. MEDISYSTEMS BLOODLINES WERE USED FOR THE TREATMENT. THERE WAS NO REPORTED DAMAGE IDENTIFIED ON THE DIALYZER. AFTER THE MACHINE ALARMED, TREATMENT WAS HALTED, AND THE PATIENT¿S BLOOD WAS NOT RETURNED. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) COULD NOT BE PROVIDED. IT WAS CONFIRMED THERE WAS NO PATIENT INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. THE PATIENT WAS ABLE TO COMPLETE TREATMENT AFTER BEING RE-SETUP WITH NEW SUPPLIES ON A DIFFERENT MACHINE. FOLLOWING THE EVENT, THE MACHINE WAS PULLED FROM SERVICE FOR EVALUATION. UPON COMPLETION OF THE INSPECTION, IT WAS CONFIRMED T

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9890535 ↗
• MalfunctionMar 27, 2020Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY BIOMEDICAL TECHNICIAN REPORTED A DIALYZER BLOOD LEAK THAT OCCURRED DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. FOLLOW UP REVEALED THAT THE BLOOD LEAK OCCURRED TOWARDS THE END OF TREATMENT, AND THE LEAK WAS REPORTED TO BE INTERNAL. THE BLOOD LEAK WAS VISUALLY OBSERVED IN THE DIALYZER. THE MACHINE, A FRESENIUS 2008T, ALARMED APPROPRIATELY WITH A BLOOD LEAK ALERT. A BLOOD LEAK TEST STRIP WAS USED TO TEST FOR THE PRESENCE OF BLOOD, AND IT TESTED POSITIVE. MEDISYSTEMS BLOODLINES WERE USED FOR THE TREATMENT. THERE WAS NO REPORTED DAMAGE IDENTIFIED ON THE DIALYZER. AFTER THE MACHINE ALARMED, TREATMENT WAS HALTED, AND THE PATIENT¿S BLOOD WAS NOT RETURNED. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) COULD NOT BE PROVIDED. IT WAS CONFIRMED THERE WAS NO PATIENT INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. AS THE LEAK OCCURRED TOWARDS THE END OF THE TREATMENT, THE PATIENT WAS NOT RE-SETUP WITH NEW SUPPLIES AND DID NOT COMPLETE THEIR TREATMENT. THERE WERE NO ADVERSE EFFECTS DUE TO THE INCOMPLETE TREATMENT. FOLLOWING THE EVENT, THE MACHINE WAS PULLED FROM SERVICE FOR EVALUATION. UPON COMPLETION OF THE IN

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9890447 ↗
• MalfunctionJan 6, 2020Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY CLINIC MANAGER (CM) REPORTED THAT AN INTERNAL DIALYZER BLOOD LEAK OCCURRED APPROXIMATELY THREE MINUTES INTO A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK WAS VISUALLY OBSERVED IN THE DIALYSATE COMPARTMENT OF THE DIALYZER. THE MACHINE, A FRESENIUS 2008T, ALARMED APPROPRIATELY WITH A BLOOD LEAK ALERT. FRESENIUS BLOODLINES WERE USED FOR THE TREATMENT. BLOOD LEAK TEST STRIPS WERE USED TO TEST FOR THE PRESENCE OF BLOOD, AND THEY TESTED POSITIVE. THERE WAS NO REPORTED DAMAGE IDENTIFIED ON THE DIALYZER. AFTER THE MACHINE ALARMED, TREATMENT WAS HALTED AND THE PATIENT¿S BLOOD WAS NOT RETURNED. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 150 ML. IT WAS CONFIRMED THERE WAS NO PATIENT INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. THE PATIENT WAS ABLE TO COMPLETE TREATMENT AFTER BEING SET UP WITH NEW SUPPLIES ON A DIFFERENT MACHINE. THE DIALYZER WAS REPORTEDLY AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9554442 ↗
• MalfunctionDec 24, 2019Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY REGISTERED NURSE (RN) REPORTED THAT AN INTERNAL DIALYZER BLOOD LEAK OCCURRED APPROXIMATELY THIRTY MINUTES INTO A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK WAS VISUALLY OBSERVED ON THE DIALYSATE SIDE OF THE DIALYZER. THERE WAS NO DAMAGE IDENTIFIED ON THE DIALYZER. THE MACHINE, A GAMBRO PHOENIX, ALARMED WITH A BLOOD LEAK. BLOOD LEAK TEST STRIPS WERE USED AND THEY TESTED POSITIVE FOR THE PRESENCE OF BLOOD. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 260 ML. THE RN CONFIRMED THERE WAS NO PATIENT INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE EVENT. THE PATIENT COMPLETED THEIR TREATMENT AFTER BEING RE-SETUP WITH NEW SUPPLIES ON A DIFFERENT MACHINE. THE COMPLAINT DEVICE WAS REPORTEDLY AVAILABLE TO BE SENT BACK TO THE MANUFACTURER FOR A PHYSICAL EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9516970 ↗
• MalfunctionDec 24, 2019Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY REGISTERED NURSE (RN) REPORTED THAT AN INTERNAL DIALYZER BLOOD LEAK OCCURRED APPROXIMATELY THREE MINUTES INTO A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK WAS VISUALLY OBSERVED ON THE DIALYSATE SIDE OF THE DIALYZER. THERE WAS NO DAMAGE IDENTIFIED ON THE DIALYZER. THE MACHINE, A GAMBRO PHOENIX, ALARMED WITH A BLOOD LEAK. BLOOD LEAK TEST STRIPS WERE USED AND THEY TESTED POSITIVE FOR THE PRESENCE OF BLOOD. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 260 ML. THE RN CONFIRMED THERE WAS NO PATIENT INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE EVENT. THE PATIENT COMPLETED THEIR TREATMENT AFTER BEING RE-SETUP WITH NEW SUPPLIES ON A DIFFERENT MACHINE. THE COMPLAINT DEVICE WAS REPORTEDLY AVAILABLE TO BE SENT BACK TO THE MANUFACTURER FOR A PHYSICAL EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9516968 ↗
• MalfunctionDec 6, 2019Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY REGISTERED NURSE (RN) REPORTED THAT AN INTERNAL DIALYZER BLOOD LEAK OCCURRED APPROXIMATELY TWENTY MINUTES INTO A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK WAS VISUALLY OBSERVED ON THE DIALYSATE SIDE OF THE DIALYZER. THERE WAS NO DAMAGE IDENTIFIED ON THE DIALYZER. THE MACHINE, A GAMBRO PHOENIX, ALARMED WITH A BLOOD LEAK. BLOOD LEAK TEST STRIPS WERE USED AND THEY TESTED POSITIVE FOR THE PRESENCE OF BLOOD. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 250 ML. THE RN CONFIRMED THERE WAS NO PATIENT INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE EVENT. THE PATIENT COMPLETED THEIR TREATMENT AFTER BEING RE-SETUP WITH NEW SUPPLIES ON A DIFFERENT MACHINE. THE COMPLAINT DEVICE WAS REPORTEDLY AVAILABLE TO BE SENT BACK TO THE MANUFACTURER FOR A PHYSICAL EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9434049 ↗
• MalfunctionNov 21, 2019Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY REPORTED THAT A DIALYZER BLOOD LEAK OCCURRED APPROXIMATELY ONE HOUR AND THIRTY MINUTES INTO A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK WAS VISUALLY OBSERVED AND WAS NOTED TO BE LEAKING EXTERNALLY FROM THE HEADER END CAP ON THE VENOUS SIDE OF THE DIALYZER. THE MACHINE, A FRESENIUS 4008S MACHINE, DID NOT ALARM. BLOOD LEAK TEST STRIPS WERE NOT USED. THERE WAS NO REPORTED DAMAGE OR DEFECTS NOTED ON THE DIALYZER. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 60 ML. THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT WAS RESTARTED ON A NEW MACHINE AND TREATMENT WAS SUCCESSFULLY COMPLETED WITH NEW SUPPLIES. THE COMPLAINT DEVICE WAS REPORTEDLY DISCARDED AND THEREFORE NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9357118 ↗
• MalfunctionSep 4, 2019Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY CLINICAL MANAGER REPORTED THAT A DIALYZER BLOOD LEAK OCCURRED IMMEDIATELY AFTER THE INITIATION OF THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK WAS NOTED AS BEING AN INTERNAL BLOOD LEAK. THE LEAK WAS NOT VISUALLY OBSERVED. THE MACHINE, A FRESENIUS 2008T MACHINE, ALARMED APPROPRIATELY WITH A BLOOD LEAK ALARM. BLOOD LEAK TEST STRIPS WERE USED AND TESTED POSITIVE FOR THE PRESENCE OF BLOOD. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 250 ML. THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, 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: No Known Impact Or Consequence To Patient

  MAUDE report 8962548 ↗
• InjuryJul 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE AT A USER FACILITY REPORTED A PATIENT WHO HAD AN ALLERGIC REACTION TO THE FRESENIUS OPTIFLUX F16NRE DIALYZER USED DURING THEIR (B)(6) 2018 TREATMENT. THE NURSE CONFIRMED THAT THE PATIENT DID NOT COMPLETE TREATMENT THAT DAY, AND WAS GIVEN ONE-TIME DOSES OF BENADRYL AND PREDNISONE TO RELIEVE THE FACIAL AND THROAT SWELLING. THE PATIENT HAD SINCE RESUMED THEIR HEMODIALYSIS TREATMENTS WITH A DIFFERENT DIALYZER WITHOUT ISSUE, AND CONFIRMED THE DIALYZER USED WHEN THE PATIENT HAD THEIR REACTION HAD BEEN DISCARDED. ADDITIONAL PATIENT INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED.

  Patient problems: Swelling

  MAUDE report 7715482 ↗