Optiflux® 0500318NRecalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 00840861100125), received between Jun 26, 2017 and Aug 31, 2026 — classified as 2 deaths, 16 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (36 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 55 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2026Fluid/Blood Leak

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50528369 ↗
• MalfunctionApr 11, 2026Fluid/Blood Leak

  A USER FACILITY CLINICAL MANAGER REPORTED THAT AN EXTERNAL DIALYZER BLOOD LEAK OCCURRED DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. ADDITIONAL DETAILS WERE PROVIDED UPON FOLLOW-UP WITH A PATIENT CARE TECHNICIAN (PCT) FROM THE FACILITY. THE BLOOD LEAK WAS FIRST NOTICED AT THE BEGINNING OF THE PATIENT¿S TREATMENT. HOWEVER, INITIALLY THERE WERE ONLY TRACE AMOUNTS OF BLOOD ON THE OUTSIDE OF THE DEVICE. THE PCT THOUGHT THE CONNECTIONS WEREN¿T TIGHT ENOUGH, SO THEY WIPED THE BLOOD OFF THE DEVICE AND TIGHTENED THE CONNECTIONS. ABOUT HALFWAY INTO THE TREATMENT, BLOOD WAS NOTICED ON THE FLOOR UNDERNEATH THE DIALYZER. AT THIS POINT, THE PCT WAS ABLE TO SEE WHERE THE BLOOD WAS COMING FROM. IT WAS LEAKING EXTERNALLY FROM UNDERNEATH THE HEADER CAP. THERE WERE NO ALARMS FROM THE MACHINE, A FRESENIUS 2008T. THERE WAS NO PHYSICAL DAMAGE OR DEFECT NOTED ON THE DIALYZER, INCLUDING AT THE LEAK LOCATION. THE PCT STOPPED THE BLOOD PUMP AND DID NOT RETURN THE PATIENT¿S BLOOD. ESTIMATED BLOOD LOSS (EBL) WAS 250 TO 300 ML. THE PCT 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 C

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24846676 ↗
• MalfunctionMar 3, 2026Fluid/Blood Leak

  A USER FACILITY NURSE REPORTED THAT A DIALYZER BLOOD LEAK OCCURRED FIFTEEN MINUTES INTO A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. ADDITIONAL DETAILS WERE PROVIDED UPON FOLLOW-UP WITH A PATIENT CARE TECHNICIAN (PCT) FROM THE FACILITY WHO WAS FAMILIAR WITH THE EVENT. THE PCT STATED BLOOD WAS OBSERVED LEAKING EXTERNALLY FROM THE ARTERIAL HEAD OF THE DIALYZER. THE LEAK SEEMED TO BE COMING THROUGH THE THREADING WHERE THE HEAD SCREWS ON. THERE WERE NO MACHINE ALARMS. NO VISIBLE DAMAGE OR DEFECTS WERE NOTED ON THE DIALYZER. AFTER THE BLOOD LEAK WAS IDENTIFIED, THE BLOOD PUMP WAS STOPPED AND THE PATIENT¿S BLOOD WAS RETURNED. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) DUE TO THE LEAK WAS LESS THAN 50 ML. THE PCT 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 24500370 ↗
• MalfunctionFeb 16, 2026Fluid/Blood Leak

  A USER FACILITY ADMINISTRATOR (FA) STATED BLOOD WAS FOUND TO BE LEAKING FROM THE ARTERIAL HEAD OF THE DIALYZER. THE LEAK WAS IDENTIFIED APPROXIMATELY 15 MINUTES INTO TREATMENT. ONCE TREATMENT STARTED AND DIALYZER WAS TURNED ARTERIAL SIDE UP BLOOD VISUALIZED IN ARTERIAL CAP. TREATMENT WAS STOPPED AND THE PATIENT'S BLOOD WAS RETURNED. A NEW CIRCUIT WAS SET UP ON THE MACHINE. UPON FOLLOW-UP, THE FA STATED AN EXTERNAL DIALYZER BLOOD LEAK OCCURRED FIFTEEN MINUTES AFTER INITIATION OF HEMODIALYSIS (HD) TREATMENT. THE MACHINE, A 2008T, DID NOT ALARM WITH A BLOOD LEAK ALERT AS THE BLOOD LEAK WAS EXTERNAL. THE BLOOD LEAK WAS VISUALLY OBSERVED FROM THE ARTERIAL HEAD OF THE DIALYZER, WHEN THE DIALYZER WAS TURNED ARTERIAL SIDE UP AND BLOOD WAS VISUALIZED LEAKING FROM THE ARTERIAL CAP. BLOOD TEST STRIPS WERE NOT USED AS THE BLOOD LEAK WAS VISIBLE AND EXTERNAL. THE PATIENT WAS UTILIZING FRESENIUS BLOODLINES. NO DAMAGE WAS NOTED ON THE DIALYZER PRIOR TO TREATMENT. THE PATIENT'S BLOOD WAS RETURNED. THE ESTIMATED BLOOD LOSS (EBL) WAS LESS THAN 100 ML. IMMEDIATELY FOLLOWING THE EVENT, THE PATIENT WAS RE-SETUP WITH NEW SUPPLIES ON THE SAME MACHINE AND COMPLETED TREATMENT WITHOUT FURTHER ISSUE. THE MAC

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24351500 ↗
• InjuryFeb 11, 2026Adverse Event Without Identified Device or Use Problem

  A USER FACILITY¿S FACILITY ADMINISTRATOR (FA) REPORTED THAT DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT USING A FRESENIUS OPTIFLUX 180 NRE DIALYZER, THE PATIENT EXPERIENCED ITCHING, SO THE PATIENT WAS SWITCHED TO THE FRESENIUS OPTIFLUX 180 NR DIALYZER FOR HEMODIALYSIS. THE PATIENT CONTINUED TO EXPERIENCE ITCHING DESPITE THE CHANGE. THE PATIENT COMPLETED TREATMENT AS EXPECTED. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 24314483 ↗
• InjuryFeb 11, 2026Adverse Event Without Identified Device or Use Problem

  A USER FACILITY¿S FACILITY ADMINISTRATOR (FA) REPORTED THAT DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT USING A FRESENIUS DIALYZER THE PATIENT EXPERIENCED SEVERE ITCHING AND LEG CRAMPING. THIS RESULTED IN THE PATIENT ENDING HEMODIALYSIS TREATMENT APPROXIMATELY 2 HOURS EARLY. THE NURSE STATED THAT THE PATIENT DID NOT REQUIRE HOSPITALIZATION AS THERE WAS NO SERIOUS HARM. THE NURSE CONFIRMED THE PATIENT DID NOT HAVE ANY SHORTNESS OF BREATH AND VITAL SIGNS REMAIN STABLE (READINGS NOT PROVIDED). HOWEVER, THE NURSE STATED THAT THE PATIENT HAD A CHANGE TO INCLUDE RINSING THE DIALYZER WITH 2 LITERS OF NORMAL SALINE FOR SUBSEQUENT DIALYSIS TREATMENTS AND A STANDING ORDER FOR BENADRYL 50 MG INTRAVENOUS (IV) FOR ITCHING AS NEEDED IN ADDITION TO THE PATIENT PRE-MEDICATING WITH BENADRYL AT HOME. ON(B)(6) 2026, THE PATIENT WAS SWITCHED TO A GAMBRO REVACLEAR 300 DIALYZER.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 24314414 ↗
• MalfunctionFeb 3, 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 WAS NOTED TO BE EXTERNAL. THE BLOOD LEAK WAS IDENTIFIED APPROXIMATELY 15 MINUTES AFTER TREATMENT INITIATION. BLOOD WAS VISUALLY OBSERVED LEAKING FROM THE ARTERIAL HEAD OF THE DIALYZER NEAR THE HANSEN CONNECTION. THE LEAK APPEARED TO BE COMING OUT OF THE THREADS OF THE CONNECTOR. NO DEFECT OR DAMAGE WAS NOTED TO THE DIALYZER. TREATMENT WAS PAUSED. THE PATIENT'S BLOOD WAS RETURNED. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) WAS NOT QUANTIFIED BUT DEFINED AS "SMALL." NO SERIOUS INJURY OR REQUIRED MEDICAL INTERVENTION RESULTED FROM THE REPORTED ISSUE. TREATMENT WAS COMPLETED ON A DIFFERENT MACHINE WITH NEW SUPPLIES. THE SAMPLE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24246604 ↗
• MalfunctionJan 26, 2026Fluid/Blood Leak

  A USER FACILITY¿S FACILITY ADMINISTRATOR (FA) REPORTED THAT A VISIBLE EXTERNAL DIALYZER BLOOD LEAK OCCURRED ONE HOUR AND 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. THERE WAS NO DEFECT OR DAMAGE NOTED ON THE DIALYZER. FRESENIUS BLOODLINES WERE ALSO IN USE. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) IS 20ML. 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 WAS REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. ONE PHOTOGRAPH HAS BEEN PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24178790 ↗
• InjuryNov 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA VOLUNTARY MEDWATCH THAT A HEMODIALYSIS (HD) PATIENT EXPERIENCED A DIALYZER REACTION DURING TREATMENT WHILE UTILIZING THE OPTIFLUX F180NR DIALYZER. THE PATIENT¿S TREATMENT WAS INITIATED ON (B)(6) 2025, AT 0611 LOCAL TIME. THE PATIENT¿S PRE-TREATMENT VITAL SIGNS WERE BLOOD PRESSURE (BP) 157/115, PULSE (P) 96, RESPIRATIONS (R) 18, AND TEMPERATURE (T) 96.7. THE TREATMENT WAS STARTED UTILIZING A FRESENIUS 2008T MACHINE, OPTIFLUX F180NR DIALYZER, COMBISET BLOODLINES, NORMAL SALINE, DIALYSATE OF GRANUFLO 2.0K, 2.5CA, 1.0MG, 100 DEXTROSE, AND NATURALYTE BICARB. AT 0848 THE PATIENT REPORTED ITCHING. THE PATIENT WAS ADMINISTERED BENADRYL 50MG INTRAVENOUS PUSH (IVP). TREATMENT WAS CONTINUED. THE PATIENT VERBALIZED RELIEF FROM THE ITCHING AT APPROXIMATELY 0900. TREATMENT WAS COMPLETED AT 1000. THE PATIENT¿S POST-TREATMENT VITALS WERE BP 110/62, P 83, R18, AND T 96.6. THE PATIENT WAS DISCHARGED HOME ALERT AND ORIENTED. THE OPTIFLUX 180NR WAS ADDED AS AN ALLERGY. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION, AND THUS FAR NO FURTHER DETAILS HAVE BEEN PROVIDED.

  Patient problems: Hypersensitivity/Allergic reaction; Itching Sensation

  MAUDE report 23677151 ↗
• InjuryOct 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 15/OCT/2025, FRESENIUS RECEIVED A MEDWATCH FORM 3500A REGARDING THIS PATIENT WITH END STAGE RENAL DISEASE (ESRD) ON HEMODIALYSIS (HD) UTILIZING A OPTIFLUX 180NR DIALYZER FOR RENAL REPLACEMENT THERAPY (RRT) REPORTEDLY EXPERIENCED A POSSIBLE DIALYZER REACTION DURING HD THERAPY ON (B)(6) 2025. VIA THE MEDWATCH FORM 3500A, THE PATIENT ARRIVED FOR HIS REGULARLY SCHEDULED OUTPATIENT HD TREATMENT ON (B)(6) 2025, AND HIS PRE-TREATMENT VITALS INCLUDED: BLOOD PRESSURE = 135/65, PULSE = 66, RESPIRATIONS = 18, TEMPERATURE = 97.6. THE TREATMENT WAS INITIATED AT 11:01 UTILIZING AN OPTIFLUX 180NR DIALYZER AS PRESCRIBED. AT APPROXIMATELY 14:41, THE PATIENT COMPLAINED OF ITCHING (PRURITUS) AND THE TREATMENT WAS TERMINATED. THE PATIENT WAS PROVIDED SUPPLEMENTAL OXYGEN (VOLUME NOT PROVIDED), INTRAVENOUS (IV) NORMAL SALINE BOLUS (VOLUME NOT PROVIDED), AND ORAL BENADRYL 50 MG. THE NURSE PRACTITIONER EVALUATED THE PATIENT CHAIRSIDE AND RECOMMENDED THE PATIENT SHOULD GO TO THE EMERGENCY ROOM, HOWEVER THE PATIENT DECLINED. AT APPROXIMATELY 14:51, THE PATIENT¿S CONDITION HAD WORSENED AND INCLUDED HIVES (PATIENT¿S TRUNK, EXTREMITIES, NECK) AND LIP SWELLING. AN INTRAMUSCULAR (IM) DOSE OF SOLU-MEDROL WAS A

  Patient problems: Hypersensitivity/Allergic reaction; Itching Sensation; Loss of consciousness; Rash; Swelling/ Edema

  MAUDE report 23395632 ↗
• MalfunctionAug 1, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY CHARGE NURSE 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 VISUALLY OBSERVED WITHIN THE HANSEN LINES. THE MACHINE, A FRESENIUS 2008T 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 150 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 22686593 ↗
• MalfunctionOct 29, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY¿S CLINIC MANAGER (CM) REPORTED THAT A VISIBLE INTERNAL DIALYZER BLOOD LEAK OCCURRED TWO MINUTES AFTER THE INITIATION OF THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE MACHINE, A FRESENIUS 2008T 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 100ML. 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 IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20556632 ↗
• MalfunctionJan 12, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY PATIENT CARE TECHNICIAN (PCT) REPORTED THAT A DIALYZER BLOOD LEAK OCCURRED DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. BLOOD WAS REPORTEDLY LEAKING OUT OF THE GROOVES AT THE SEAL. ADDITIONAL DETAILS WERE PROVIDED UPON FOLLOW-UP WITH THE FACILITY¿S CHARGE NURSE (CN). THE CN STATED THE BLOOD LEAK OCCURRED ABOUT FIFTEEN MINUTES INTO THE TREATMENT. THEY CONFIRMED BLOOD WAS SEEN LEAKING EXTERNALLY FROM THE HEADER OF THE DIALYZER. THE MACHINE DID NOT PRODUCE AN ALARM, AND THE DIALYSATE WAS NOT TESTED WITH A BLOOD TEST STRIP. NO PHYSICAL DAMAGE WAS NOTICED ON THE DIALYZER, AT THE LEAK LOCATION OR ELSEWHERE. ONCE THE LEAK WAS NOTICED, THE TREATMENT WAS STOPPED AND THE PATIENT¿S BLOOD WAS NOT RETURNED. ESTIMATED BLOOD LOSS (EBL) WAS REPORTEDLY LESS THAN 200 ML. THE CN 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 THEIR TREATMENT AFTER BEING RE-SETUP WITH NEW SUPPLIES ON THE SAME MACHINE. THE DIALYZER WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION AS IT WAS REPORTEDLY DISCARDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18504759 ↗
• MalfunctionOct 24, 2023Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY REGISTERED NURSE (RN) REPORTED THAT AN INTERNAL DIALYZER BLOOD LEAK OCCURRED AT THE VERY BEGINNING OF A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK WAS VISUALLY OBSERVED IN THE DIALYSATE COMPARTMENT OF THE DIALYZER. THE RN WAS STANDING IN FRONT OF THE MACHINE MONITORING THE START OF THE TREATMENT WHEN THEY NOTICED BLOOD OUTSIDE THE FIBERS AT THE TOP OF THE DIALYZER (IN THE HEADER). THE RN STOPPED THE BLOOD PUMP BEFORE BLOOD COULD REACH THE BLOOD LEAK DETECTOR. THE MACHINE, A FRESENIUS 2008T, DID NOT PRODUCE A BLOOD LEAK ALARM. THE RN REPORTED THAT THE BLOOD HAD NOT TRAVELED TO THE OTHER END OF THE DIALYZER WHEN THE LEAK WAS CAUGHT. A BLOOD LEAK TEST STRIP WAS USED TO TEST THE DIALYSATE FOR BLOOD, AND IT TESTED POSITIVE. NO PHYSICAL DAMAGE WAS OBSERVED ON THE DIALYZER. THE PATIENT¿S BLOOD WAS NOT RETURNED FOLLOWING THE EVENT; ESTIMATED BLOOD LOSS (EBL) WAS 250 ML. THE PATIENT¿S TREATMENT WAS COMPLETED AFTER THEY WERE RESTARTED WITH NEW SUPPLIES ON THE SAME MACHINE. 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 REPORTEDLY AVAILABL

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17997486 ↗
• MalfunctionOct 23, 2023Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY CERTIFIED CLINICAL HEMODIALYSIS TECHNICIAN (CCHT) REPORTED A DIALYZER BLOOD LEAK OCCURRED DURING A PATIENT'S HEMODIALYSIS (HD) TREATMENT. TREATMENT WAS DISCONTINUED AND THE PATIENT'S BLOOD WAS NOT RETURNED. UPON FOLLOW-UP, THE CLINIC MANAGER (CM) STATED IMMEDIATELY AFTER INITIATION OF HD TREATMENT, BLOOD WAS NOTICED LEAKING FROM A CRACK IN THE DIALYZER HEAD. PER CM THE BLOOD LEAK WAS EXTERNAL. THE MACHINE, A 2008T, WAS USED AND STATED THE MACHINE DID NOT ALARM WITH A BLOOD LEAK ALERT. BLOOD TEST STRIPS WERE USED AND TESTED NEGATIVE FOR THE PRESENCE OF BLOOD. THE PATIENT WAS UTILIZING FRESENIUS COMBI SET BLOODLINES AND THE PATIENT'S BLOOD WAS NOT RETURNED. NO DAMAGE WAS NOTED ON THE DIALYZER PRIOR TO TREATMENT. IMMEDIATELY FOLLOWING THE EVENT, THE PATIENT WAS RE-SETUP WITH NEW SUPPLIES ON THE SAME MACHINE AND COMPLETED TREATMENT WITHOUT ISSUE. THE ESTIMATED BLOOD LOSS WAS 300ML. 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 NO LONGER AVAILABLE TO BE RETURNED FOR MANUFACTURER EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17987123 ↗
• InjuryAug 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, FRESENIUS BECAME AWARE A PATIENT WITH END STAGE RENAL DISEASE (ESRD) ON HEMODIALYSIS (HD) UTILIZING A OPTIFLUX 180NRE DIALYZER FOR RENAL REPLACEMENT THERAPY (RRT) REPORTEDLY EXPERIENCED ALLERGIC REACTIONS, WHICH CAUSED ITCHING (PRURITIS). NO ADDITIONAL INFORMATION WAS PROVIDED DURING INTAKE. FOLLOW-UP WITH THE CLINICAL MANAGER (CM) REVEALED THERE WERE A PATIENT EXPERIENCED PRURITUS DURING HD THERAPY. ADDITIONAL INFORMATION (PATIENT DEMOGRAPHICS, HD ORDERS, MEDICATION RECORDS, HOSPITAL RECORDS) WAS REQUESTED VIA EMAIL, HOWEVER NO RESPONSE HAS BEEN RECEIVED. DESPITE THE LACK OF DETAILED FOLLOW-UP, THE CM REPORTED THE PATIENT IS NOW UNDERGOING HD THERAPY UTILIZING A NIPRO CELLENTIA DIALYZER WITHOUT FURTHER INCIDENT.

  Patient problems: Hypersensitivity/Allergic reaction; Itching Sensation

  MAUDE report 17650978 ↗
• InjuryAug 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, FRESENIUS BECAME AWARE A PATIENT WITH END STAGE RENAL DISEASE (ESRD) ON HEMODIALYSIS (HD) UTILIZING A OPTIFLUX 180NRE DIALYZER FOR RENAL REPLACEMENT THERAPY (RRT) REPORTEDLY EXPERIENCED ALLERGIC REACTIONS, WHICH CAUSED ITCHING (PRURITIS). NO ADDITIONAL INFORMATION WAS PROVIDED DURING INTAKE. FOLLOW-UP WITH THE CLINICAL MANAGER (CM) REVEALED THERE WERE A PATIENT EXPERIENCED PRURITUS DURING HD THERAPY. ADDITIONAL INFORMATION (PATIENT DEMOGRAPHICS, HD ORDERS, MEDICATION RECORDS, HOSPITAL RECORDS) WAS REQUESTED VIA EMAIL, HOWEVER NO RESPONSE HAS BEEN RECEIVED. DESPITE THE LACK OF DETAILED FOLLOW-UP, THE CM REPORTED THE PATIENT IS NOW UNDERGOING HD THERAPY UTILIZING A NIPRO CELLENTIA DIALYZER WITHOUT FURTHER INCIDENT.

  Patient problems: Hypersensitivity/Allergic reaction; Itching Sensation

  MAUDE report 17650958 ↗
• InjuryAug 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, FRESENIUS BECAME AWARE A PATIENT WITH END STAGE RENAL DISEASE (ESRD) ON HEMODIALYSIS (HD) UTILIZING A OPTIFLUX 180NRE DIALYZER FOR RENAL REPLACEMENT THERAPY (RRT) REPORTEDLY EXPERIENCED ALLERGIC REACTIONS, WHICH CAUSED ITCHING (PRURITIS). NO ADDITIONAL INFORMATION WAS PROVIDED DURING INTAKE. FOLLOW-UP WITH THE CLINICAL MANAGER (CM) REVEALED THERE WAS A PATIENT EXPERIENCING PRURITUS DURING HD THERAPY. ADDITIONAL INFORMATION (PATIENT DEMOGRAPHICS, HD ORDERS, MEDICATION RECORDS, HOSPITAL RECORDS) WAS REQUESTED VIA EMAIL, HOWEVER NO RESPONSE HAS BEEN RECEIVED. DESPITE THE LACK OF DETAILED FOLLOW-UP, THE CM REPORTED THE PATIENT IS NOW UNDERGOING HD THERAPY UTILIZING A NIPRO CELLENTIA DIALYZER WITHOUT FURTHER INCIDENT.

  Patient problems: Hypersensitivity/Allergic reaction; Itching Sensation

  MAUDE report 17648085 ↗
• MalfunctionAug 17, 2023Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY REPORTED THAT A DIALYZER BLOOD LEAK OCCURRED LESS THAN ONE MINUTE (AS SOON AS THE BLOOD HIT THE DIALYZER) 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 IN THE DIALYZER AND IN THE DRAIN LINES. THE MACHINE, A FRESENIUS 2008K MACHINE, ALARMED APPROPRIATELY WITH A BLOOD LEAK ALARM. 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 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 NOT BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17565419 ↗
• MalfunctionJan 4, 2023Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED A DIALYZER BLOOD LEAK THAT OCCURRED DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOW-UP WITH THE FACILITY. A NURSE FAMILIAR WITH THE EVENT STATED THE BLOOD LEAK OCCURRED APPROXIMATELY TWO HOURS AND TEN MINUTES INTO THE TREATMENT. THE BLOOD LEAK WAS REPORTED TO BE INTERNAL. THE NURSE STATED THE BLOOD LEAK WAS VISUALLY OBSERVED IN THE DIALYSATE COMPARTMENT OF THE DIALYZER. BLOOD STREAKS WERE NOTED ON THE OUTSIDE OF THE FIBER BUNDLE. THE MACHINE, A FRESENIUS 2008T MACHINE, ALARMED APPROPRIATELY WITH A BLOOD LEAK ALARM. B. BRAUN BLOODLINES WERE BEING UTILIZED FOR THE TREATMENT. A BLOOD TEST STRIP WAS USED, AND IT TESTED POSITIVE FOR THE PRESENCE OF BLOOD. NO VISIBLE DAMAGE WAS OBSERVED ON THE DIALYZER. AFTER THE MACHINE ALARMED, THE TREATMENT WAS PAUSED. THE PATIENT¿S BLOOD WAS NOT RETURNED; THEIR ESTIMATED BLOOD LOSS (EBL) WAS 250 ML. THE NURSE 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 RESETUP WITH NEW SUPPLIES ON A DIFFERENT MAC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16097810 ↗
• MalfunctionNov 4, 2022Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY CLINICAL MANAGER (CM) REPORTED THAT A BLOOD LEAK OCCURRED AT THE BEGINNING OF A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. IT WAS REPORTED THAT BLOOD WAS SEEN LEAKING EXTERNALLY FROM THE VENOUS CONNECTOR OF THE COMBI SET BLOODLINE, WHERE THE COMBI SET CONNECTS WITH THE DIALYZER. THE CM STATED THAT THE VENOUS CONNECTOR DISCONNECTED FROM THE OPTIFLUX DIALYZER. THE MACHINE, A FRESENIUS 2008T HD MACHINE, DID NOT PRODUCE ANY ALARMS. THERE WERE NO DEFECTS OBSERVED ON THE OPTIFLUX DIALYZER OR ON THE COMBI SET BLOODLINE, INCLUDING AT THE SITE OF THE DISCONNECTION/LEAK. THE CM SAID THE THREADING OF BOTH DEVICES APPEARED NORMAL, AND THE CONNECTION WAS CONFIRMED TO BE SECURE PRIOR TO TREATMENT INITIATION. FURTHERMORE, THERE WERE NO LEAKS NOTED DURING THE PRIMING PHASE. FOLLOWING THE LEAK, THE PATIENT¿S BLOOD WAS NOT RETURNED; ESTIMATED BLOOD LOSS (EBL) WAS 100 ML. THE CM 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 RESETUP WITH NEW SUPPLIES ON THE SAME MACHINE. THE DIALYZER WAS NOT AVAILABLE TO BE RETURNED FOR MANUFACTURER EVALUATIO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15736863 ↗
• MalfunctionOct 19, 2022Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY REGISTERED NURSE (RN) REPORTED THAT AN INTERNAL DIALYZER BLOOD LEAK OCCURRED A HOUR AND A HALF AFTER THE START OF A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE RN CONFIRMED NO EXTERNAL BLOOD LEAK WAS OBSERVED. THE MACHINE, A FRESENIUS 2008T, ALARMED APPROPRIATELY WITH A MINOR BLOOD LEAK ALERT. FRESENIUS COMBI SET BLOODLINES WERE BEING UTILIZED FOR THE TREATMENT. BLOOD TEST STRIPS WERE USED AND TESTED POSITIVE FOR THE PRESENCE OF BLOOD. NO DAMAGE WAS IDENTIFIED ON THE DIALYZER PRIOR TO USE. PER RN THE PATIENT¿S BLOOD WAS NOT RETURNED AND STATED THE ESTIMATED BLOOD LOSS (EBL) WAS 200 ML. IMMEDIATELY FOLLOWING THE EVENT, THE PATIENT WAS RE-SETUP WITH NEW SUPPLIES ON A DIFFERENT MACHINE WHERE THEY WERE ABLE TO COMPLETE TREATMENT. 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 AVAILABLE TO BE RETURNED FOR MANUFACTURER EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15633718 ↗
• MalfunctionOct 15, 2022Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY REGISTERED NURSE (RN) REPORTED THAT AN INTERNAL DIALYZER BLOOD LEAK OCCURRED FIVE MINUTES AFTER THE START OF A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE RN CONFIRMED NO EXTERNAL BLOOD LEAK WAS OBSERVED. THE MACHINE, A FRESENIUS 2008T, ALARMED APPROPRIATELY WITH A MINOR BLOOD LEAK ALERT. FRESENIUS COMBI SET BLOODLINES WERE BEING UTILIZED FOR THE TREATMENT. BLOOD TEST STRIPS WERE USED AND TESTED FOR THE PRESENCE OF BLOOD. NO DAMAGE WAS IDENTIFIED ON THE DIALYZER PRIOR TO USE. PER RN THE PATIENT¿S BLOOD WAS NOT RETURNED AND STATED THE ESTIMATED BLOOD LOSS (EBL) WAS 300 ML. IMMEDIATELY FOLLOWING THE EVENT, THE PATIENT WAS RE-SETUP WITH NEW SUPPLIES ON A DIFFERENT MACHINE WHERE THEY WERE ABLE TO COMPLETE TREATMENT. 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 DISCARDED AND WAS AVAILABLE TO BE RETURNED FOR MANUFACTURER EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15612527 ↗
• InjuryApr 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO FRESENIUS THAT A HEMODIALYSIS (HD) PATIENT EXPERIENCED PRURITUS (WRIST) DURING HD THERAPY ON (B)(6) 2022. WHILE HOSPITALIZED, THE PATIENT UNDERWENT HD THERAPY (HEPARIN FREE), WITH COMPLAINTS OF WRIST ITCHING, AND WAS GIVEN INTRAVENOUS (IV) BENADRYL (DOSE NOT PROVIDED). THE PATIENT UNDERWENT HD AGAIN ON FRIDAY (B)(6) 2022 (WITH HEPARIN, NO BENADRYL) WITHOUT ISSUE AND WAS DISCHARGED HOME.

  Patient problems: Itching Sensation

  MAUDE report 14215034 ↗
• DeathApr 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A HEMODIALYSIS (HD) PATIENT ¿FEELING UNWELL,¿ LOSS OF CONSCIOUSNESS, PULSELESSNESS, AND SUBSEQUENT DEATH ON (B)(6) 2022. THE PATIENT ARRIVED AT THEIR OUTPATIENT DIALYSIS CLINIC ON (B)(6) 2022 FOR HIS REGULARLY SCHEDULED TREATMENT, AND THE PATIENT¿S PRE-TREATMENT VITALS INCLUDED A B/P = 108/68 (SITTING), 103/67 (STANDING), PULSE = 93 BPM, RESPIRATIONS = 16 PER MIN, TEMPERATURE = 96.4, OXYGEN SATURATION = 94% AND A PRE-TREATMENT WEIGHT OF (B)(6) KGS. THE TREATMENT WAS INITIATED AT 6:18 AM (ULTRAFILTRATION GOAL = 3.5 KGS AS TOLERATED) AND TERMINATED AT 6:23 AM AFTER THE PATIENT COMPLAINED OF NOT FEELING WELL. WHILE THE REGISTERED NURSE (RN) WAS ASSESSING THE PATIENT, THEY BECAME UNRESPONSIVE (IT IS UNKNOWN IF THE PATIENT¿S BLOOD WAS RETURNED) AND A PULSE COULD NOT BE PALPATED. THE PATIENT WAS PLACED IN THE TRENDELENBURG POSITION, EMERGENCY MEDICAL SERVICES (EMS) WAS CONTACTED, AND THE CODE CART WAS RETRIEVED. CARDIOPULMONARY RESUSCITATIVE (CPR) MEASURES WERE INSTITUTED, AND AN AUTOMATED EXTERNAL DEFIBRILLATOR (AED) WAS APPLIED. NO SHOCK WAS ADVISED, AND CPR WAS CONTINUED UNTIL EMS ARRIVED AT 6:30 AM. EMS CODED THE PATIENT (SPECIFICS NOT PROVIDED) UNTIL 7:06 AM AT

  Patient problems: Loss of consciousness

  MAUDE report 14215016 ↗