Optiflux® 0500308ERecalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00840861100088), received between Oct 30, 2017 and Sep 17, 2025 — classified as 28 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (28 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 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A REGISTERED NURSE (RN) REPORTED A DIALYZER BLOOD LEAK ASSOCIATED WITH HEMODIALYSIS (HD) TREATMENT. IN A FOLLOW UP, THE NURSE REPORTED THAT THE BLOOD LEAK OCCURRED ABOUT 2 HOURS INTO THE HD TREATMENT. THE NURSE EXPLAINED THAT THE LEAK WAS NOT VISUALLY SEEN. THE BLOOD LEAK WAS DESCRIBED AS BEING AN INTERNAL BLOOD LEAK. A FRESENIUS 2008T MACHINE WAS BEING USED. THE MACHINE DID ALARM APPROPRIATELY WITH A BLOOD LEAK ALARM. BLOOD LEAK TEST STRIPS WERE USED AND TESTED POSITIVE FOR THE PRESENCE OF BLOOD. FRESENIUS BLOODLINES WERE USED. THERE WAS NO DAMAGE NOTED ON THE DIALYZER. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS 200 ML. THERE WAS NO PATIENT INJURY, ADVERSE EVENT OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE TREATMENT WAS COMPLETED ON 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 23080086 ↗
• MalfunctionOct 4, 2022Fluid/Blood Leak; Fluid/Blood Leak

  A MEDICAL WORKER REPORTED THAT DURING HEMODIALYSIS (HD) TREATMENT THERE WAS A BLOOD LEAK (CLOT). IN A FOLLOW UP, IT WAS VERIFIED THAT THE CLOT (LEAK) OCCURRED ABOUT 1 HOUR AFTER STARTING THE HD TREATMENT. THE REPORTER STATED THAT AFTER ONE HOUR OF STARTING THE TREATMENT THE ALARM OF ARTERIAL PRESSURE, AIR, VENOUS PRESSURE AND TRANSMEMBRANE PRESSURE WERE ACTIVATED. WHEN THE STAFF MADE AN INSPECTION IT WAS DETECTED THAT THERE WERE CLOTS THAT CAUSED THE TREATMENT TO BE STOPPED. BLOOD TEST STRIPS WERE NOT USED. THE MACHINE, A FRESENIUS 4008S MACHINE, ALARMED APPROPRIATELY WITH THE ALARM. FRESENIUS BLOODLINES WERE USED. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS 300 ML. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THERE WAS NO VISIBLE DAMAGE TO THE DIALYZER. THE TREATMENT WAS COMPLETED THE SAME DAY WITH NEW SUPPLIES ON THE SAME MACHINE. THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15538786 ↗
• MalfunctionOct 19, 2020Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY NURSE REPORTED THAT A DIALYZER BLOOD LEAK OCCURRED 20 MINUTES INTO A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK WAS CONFIRMED TO BE INTERNAL AND VISUALLY OBSERVED. THE MACHINE, A FRESENIUS 4008S MACHINE, ALARMED APPROPRIATELY WITH A BLOOD LEAK ALARM. THERE WAS NO DEFECT OR DAMAGE SEEN ON THE DIALYZER. 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 ABLE TO COMPLETE TREATMENT THAT DAY ON THE SAME MACHINE WITH NEW SUPPLIES. THE COMPLAINT DEVICE WAS REPORTED TO BE UNAVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10696485 ↗
• MalfunctionSep 10, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A BLOOD LEAK OCCURRED ABOUT FOUR MINUTES INTO A PATIENT'S HEMODIALYSIS (HD) TREATMENT. THE STAFF DETECTED THE INTERNAL BLOOD LEAK IMMEDIATELY AND REPLACED THE DIALYZER FOR A NEW ONE. UPON FOLLOW-UP WITH THE CLINIC, IT WAS REPORTED THAT THE MACHINE, A FRESENIUS 4008S MACHINE, ALARMED APPROPRIATELY WITH A BLOOD LEAK ALARM. THE LEAK WAS VISUALLY OBSERVED FROM BROKEN MEMBRANES IN THE DIALYZER. BLOOD TEST STRIPS WERE NOT USED. 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, ADVERSE EVENTS, 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 RETURNED TO THE MANUFACTURER FOR EVALUATION BECAUSE IT WAS DISCARDED. A PHOTO OF THE REPORTED ISSUE WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10518243 ↗
• MalfunctionAug 20, 2020Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY IN (B)(6) REPORTED TO FRESENIUS (B)(4) TECHNICAL SERVICES THAT AFTER 5 MINUTES OF INITIATING HEMODIALYSIS (HD) TREATMENT THE NURSING STAFF OBSERVED BLOOD LEAKING FROM THE ARTERIAL HEAD CAP OF THE DIALYZER. THERE WAS NO ADVERSE EVENT, INJURY, NOR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED EVENT. THE ESTIMATED BLOOD LOSS WAS 250ML. THE PATIENT'S BLOOD FLOW RATE WAS 350 ML/MIN, AND DIALYSIS FLOW RATE WAS 500. PATIENT HAS BEEN RECEIVING HD TREATMENTS 3 TIMES A WEEK SINCE (B)(6) 2020. THE DIALYZER WAS REPLACED AND THE HD TREATMENT WAS COMPLETED ON THE SAME HD SYSTEM. THERE ARE NO SAMPLE AVAILABLE TO RETURN.

  Patient problems: Blood Loss

  MAUDE report 10435331 ↗
• MalfunctionJul 22, 2020Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY NURSE REPORTED THAT A DIALYZER BLOOD LEAK OCCURRED 5 MINUTES AFTER THE INITIATION OF THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK WAS NOTED AS BEING AN INTERNAL BLOOD LEAK. THE MACHINE, A FRESENIUS 4008S MACHINE, ALARMED APPROPRIATELY WITH A BLOOD LEAK ALARM. BLOOD LEAK TEST STRIPS WERE NOT USED AS THE LEAK WAS OBSERVED IN THE ARTERIAL HEAD CAP OF THE DIALYZER. 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, ADVERSE EVENTS, 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 IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION BECAUSE IT WAS DISCARDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10310630 ↗
• MalfunctionJul 21, 2020Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY NURSE REPORTED THAT AN INTERNAL DIALYZER BLOOD LEAK OCCURRED APPROXIMATELY THIRTY MINUTES INTO A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. DURING INSPECTION OF THE DEVICE, THE STAFF VISUALLY OBSERVED THE BLOOD LEAK IN THE ARTERIAL HEADER CAP OF THE DIALYZER. 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. THERE WAS NO VISIBLE DAMAGE IDENTIFIED ON THE DIALYZER. AFTER THE MACHINE ALARMED, THE TREATMENT WAS DISCONTINUED. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 2 ML. MOST OF THE PATIENT¿S BLOOD WAS REPORTEDLY RETURNED. 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 COMPLETED TREATMENT AFTER BEING RE-SETUP WITH NEW SUPPLIES ON A DIFFERENT MACHINE. THE DIALYZER WAS NOT AVAILABLE TO BE RETURNED FOR A MANUFACTURER EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10303626 ↗
• MalfunctionMay 28, 2020Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY NURSE REPORTED THAT A DIALYZER BLOOD LEAK OCCURRED ONE MINUTE 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 ON THE ARTERIAL HEAD CAP OF THE DIALYZER. THERE WAS NO DEFECT OR DAMAGE NOTED ON THE DIALYZER. THE MACHINE, A FRESENIUS 4008S MACHINE, ALARMED APPROPRIATELY WITH A BLOOD LEAK ALARM. BLOOD LEAK TEST STRIPS WERE NOT USED. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 10 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 DISCARDED AND NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10097558 ↗
• MalfunctionMar 16, 2020Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY NURSE REPORTED THAT AN INTERNAL DIALYZER BLOOD LEAK OCCURRED TWO MINUTES INTO A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE MACHINE, A FRESENIUS 4008S, ALARMED WITH A BLOOD LEAK ALERT. UPON INSPECTION OF THE DEVICE, THE STAFF REPORTEDLY IDENTIFIED BROKEN FIBER MEMBRANES IN THE UPPER HEADER CAP OF THE DIALYZER. THE TYPE OF BLOODLINES IN USE WAS UNKNOWN. BLOOD LEAK TEST STRIPS WERE NOT USED. THE SITUATION WAS ADDRESSED IMMEDIATELY, AND THE PATIENT WAS MOVED TO A DIFFERENT MACHINE. THE PATIENT SUCCESSFULLY COMPLETED THEIR TREATMENT AFTER BEING RE-SETUP WITH NEW SUPPLIES. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS REPORTEDLY 3 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 MANUFACTURER EVALUATION AS IT WAS REPORTEDLY DISCARDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9833480 ↗
• MalfunctionDec 2, 2019Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY NURSE REPORTED THAT A DIALYZER BLOOD LEAK OCCURRED 40 MINUTES AFTER THE INITIATION OF THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK WAS NOTED AS BEING AN INTERNAL BLOOD LEAK. THE MACHINE, A FRESENIUS 4008S MACHINE, ALARMED APPROPRIATELY WITH A BLOOD LEAK ALARM. BLOOD LEAK TEST STRIPS WERE NOT USED. THERE WAS NO DEFECT OR DAMAGE NOTED ON THE DIALYZER. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 3 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 DISCARDED AND NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9395241 ↗
• MalfunctionNov 7, 2019Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY NURSE REPORTED THAT A DIALYZER BLOOD LEAK OCCURRED 35 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 ON THE BODY OF THE DIALYZER. THE MACHINE, A FRESENIUS 4008S MACHINE, ALARMED APPROPRIATELY WITH A BLOOD LEAK ALARM. BLOOD LEAK TEST STRIPS WERE NOT USED. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 5 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 DISCARDED AND NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9292286 ↗
• MalfunctionSep 30, 2019Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY NURSE REPORTED THAT AFTER THE EXTRACORPOREAL CIRCUIT FILLED WITH BLOOD DURING A PATIENT¿S TREATMENT, THERE WAS A SOLUTION LEAK. THE LEAK WAS NOTED AS BEING AN EXTERNAL LEAK. THE LEAK WAS VISUALLY OBSERVED. THE MACHINE, A FRESENIUS 4008S MACHINE DID NOT ALARM. THE NURSE REPORTED THAT THERE WAS NO PATIENT BLOOD LOSS, HOWEVER VIDEO EVIDENCE SHOWED BLOOD IN THE DIALYZER AT THE TIME OF THE EVENT. IT WAS UNKNOWN IF THE PATIENT¿S BLOOD WAS ABLE TO BE RINSED BACK. THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, 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 DIALYZER WAS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9135845 ↗
• MalfunctionSep 18, 2019Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY NURSE REPORTED THAT A DIALYZER BLOOD LEAK OCCURRED 15 MINUTES INTO THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THERE WAS DAMAGE AND A BLOOD LEAK OBSERVED AT THE UPPER HEAD CAP OF THE DIALYZER. THE FRESENIUS 4008S MACHINE DID NOT ALARM. THE PATIENT WAS RESTARTED WITH NEW SUPPLIES. THE AMOUNT OF BLOOD LOSS WAS NOT PROVIDED. THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED EVENT. THE PATIENT WAS RESTARTED ON THE SAME MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THE DIALYZER WAS DISCARDED AND IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9083196 ↗
• MalfunctionAug 26, 2019Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY CLINIC NURSE REPORTED THAT A DIALYZER BLOOD LEAK OCCURRED DURING THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. A BROKEN PART ON THE UPPER HEAD CAP OF THE DIALYZER WAS OBSERVED DURING TREATMENT. UPON FOLLOW UP, THE BLOOD LEAK OCCURRED IMMEDIATELY AFTER CONNECTING BOTH LINES TO THE PATIENT. THE FRESENIUS 2008K2 MACHINE ALARMED APPROPRIATELY WITH A BLOOD LEAK ALARM. FRESENIUS BLOOD LINES WERE USED DURING TREATMENT. BLOOD STRIPS WERE NOT USED. THE BLOOD LEAK WAS NOTED AS EXTERNAL. THERE WERE NO DEFECTS REPORTED TO THE DIALYZER. THE PATIENT¿S ESTIMATED BLOOD LOSS WAS 100 ML. THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT SUCCESSFULLY COMPLETED TREATMENT ON THE SAME MACHINE WITH NEW SUPPLIES. THE COMPLAINT DEVICES WERE DISCARDED AND ARE NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8930466 ↗
• MalfunctionJul 15, 2019Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY NURSE REPORTED THAT A BLOOD LEAK OCCURRED FROM THE UPPER HEAD OF THE DIALYZER 10 MINUTES AFTER THE INITIATION OF THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE 4008 S MACHINE DID NOT ALARM. THE MACHINE SERIAL NUMBER WAS REQUESTED, HOWEVER NOT PROVIDED. THE BLOOD LEAK WAS NOTED AS BEING AN INTERNAL BLOOD LEAK. INFORMATION ON THE BLOODLINES USED WAS REQUESTED, HOWEVER NOT PROVIDED. THERE WAS NO DEFECT OR DAMAGE SEEN ON THE DIALYZER. 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 DIALYZER WAS DISCARDED AND IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8789517 ↗
• MalfunctionFeb 18, 2019Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY REPORTED THAT A DIALYZER BLOOD LEAK OCCURRED THREE MINUTES AFTER THE INITIATION OF THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. IT WAS NOTED THAT THE BLOOD LEAK WAS COMING FROM THE UPPER HEAD OF THE DIALYZER. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) WAS 20 ML. UPON FOLLOW UP, IT WAS CONFIRMED THAT THE MACHINE, A FRESENIUS 4008S MACHINE, ALARMED APPROPRIATELY WITH A BLOOD LEAK ALARM. BLOOD LEAK TEST STRIPS WERE NOT USED. THE LEAK WAS CONFIRMED TO BE INTERNAL. THERE WAS NO DEFECT OR DAMAGE SEEN ON THE DIALYZER. THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED EVENT. THE PATIENT WAS RESTARTED ON A NEW MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THE DIALYZER WAS DISCARDED AND IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8348051 ↗
• MalfunctionFeb 11, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A DIALYZER BLOOD LEAK OCCURRED ONE MINUTE AFTER THE INITIATION OF THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK WAS NOTED AS BEING AN INTERNAL BLOOD LEAK. THE MACHINE, A FRESENIUS 2008K2 MACHINE, ALARMED APPROPRIATELY WITH A BLOOD LEAK ALARM. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 80ML. 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 HAVE BEEN DISCARDED AND IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8325977 ↗
• MalfunctionFeb 5, 2019Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY REPORTED THAT A DIALYZER BLOOD LEAK OCCURRED 2 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 NOT VISUALLY OBSERVED. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 1ML. 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 NOT AVAILABLE FOR RETURN TO THE MANUFACTURER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8307702 ↗
• MalfunctionNov 19, 2018Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY REPORTED A DIALYZER BLOOD LEAK FROM A FRESENIUS OPTIFLUX F18NRE DIALYZER THAT OCCURRED DURING PATIENT TREATMENT. THE BLOOD LEAK WAS OBSERVED 5 MINUTES AFTER THE START OF TREATMENT. THE DIALYZER AND BLOODLINES WERE REPLACED, AND THE PATIENT COMPLETED TREATMENT ON THE SAME FRESENIUS 4008S MACHINE WITH NO INJURY, ADVERSE EVENT, OR MEDICAL INTERVENTION. THE DIALYZER WAS DISCARDED AND WAS NOT AVAILABLE FOR RETURN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8083904 ↗
• MalfunctionNov 15, 2018Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY CLINICAL MANAGER REPORTED THAT A DIALYZER BLOOD LEAK OCCURRED AFTER THE INITIATION OF THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK WAS NOTED AS BEING AN INTERNAL BLOOD LEAK. THE FRESENIUS 4008S CLASSIC MACHINE SOUNDED A BLOOD LEAK ALARM. THE LEAK WAS VISUALLY OBSERVED THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 5ML. THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, 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 REPORTEDLY NOT AVAILABLE FOR RETURN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8073460 ↗
• MalfunctionAug 7, 2018Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY ADMINISTRATOR REPORTED THAT NURSING STAFF OBSERVED A FRESENIUS OPTIFLUX F18NRE DIALYZER HAD A BLOOD LEAK DURING PATIENT TREATMENT. IT WAS REPORTED THAT THE MEMBRANE OF THE DIALYZER WAS BROKEN, AND RESULTED IN A BLOOD LEAK. IT WAS CONFIRMED THAT THE DIALYZER WAS CHANGED OUT, AND THE LEAKING DIALYZER WAS DISCARDED. DUE DILIGENCE ATTEMPTS WERE EXHAUSTED, BUT ADDITIONAL INFORMATION WAS NOT PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7759935 ↗
• MalfunctionJul 24, 2018Fluid/Blood Leak; Fluid/Blood Leak

  A COMPANY REPRESENTATIVE REPORTED THAT A DIALYZER BLOOD LEAK OCCURRED 13 MINUTES AFTER THE INITIATION OF THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK WAS NOTED AS BEING AN EXTERNAL BLOOD LEAK. THE LEAK WAS VISUALLY OBSERVED. THE MACHINE, A FRESENIUS 2008K MACHINE, DID NOT SOUND A BLOOD LEAK ALARM. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS UNKNOWN. THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, 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.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7714244 ↗
• MalfunctionJul 8, 2018Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY CLINICAL ADMINISTRATOR REPORTED THAT A DIALYZER BLOOD LEAK OCCURRED 25 MINUTES AFTER THE INITIATION OF THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK WAS NOTED AS BEING AN EXTERNAL BLOOD LEAK. THE LEAK WAS VISUALLY OBSERVED IN THE DIALYZER MEMBRANE. THE MACHINE, A FRESENIUS 4008S MACHINE, DID NOT GIVE A BLOOD LEAK ALARM. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 80ML. THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, 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 DISCARDED AND WAS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7668701 ↗
• MalfunctionMay 3, 2018Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY REPORTED THAT A DIALYZER BLOOD LEAK THAT OCCURRED APPROXIMATELY FIFTEEN MINUTES INTO THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK WAS NOTED AS BEING AN EXTERNAL BLOOD LEAK. THE MACHINE, A FRESENIUS 4008S MACHINE, ALARMED APPROPRIATELY WITH A BLOOD LEAK ALARM. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 15 ML. THERE WAS NO DEFECT OR DAMAGE SEEN ON THE DIALYZER. WAS NO PATIENT INJURY, ADVERSE EVENTS, 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 DISCARDED AND IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7483850 ↗
• MalfunctionMay 3, 2018Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY REPORTED THAT A DIALYZER BLOOD LEAK THAT OCCURRED AT THE BEGINNING OF THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK WAS NOTED AS BEING AN EXTERNAL BLOOD LEAK. THE LEAK WAS NOTED IN THE UPPER HEAD OF THE DIALYZER. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 10 ML. THERE WAS NO DEFECT OR DAMAGE SEEN ON THE DIALYZER. THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, 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 DISCARDED AND IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7483759 ↗