Optiflux® 0500316NRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00840861100118), received between Sep 13, 2017 and Sep 16, 2021 — classified as 1 death, 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2021Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY 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 ON THE HANSON AND WAS SEEN LEAKING THROUGH THE HANSON. THE MACHINE, A FRESENIUS 2008T MACHINE, ALARMED APPROPRIATELY WITH A BLOOD LEAK ALARM. BLOOD LEAK TEST STRIPS WERE NOT USED. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12482076 ↗
• InjuryJun 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO FRESENIUS BY A NEPHROLOGIST THAT THIS PATIENT WITH END STAGE RENAL DISEASE (ESRD) ON HEMODIALYSIS (HD) FOR RENAL REPLACEMENT THERAPY (RRT) EXPERIENCED A REPORTED REACTION (SPECIFICS NOT PROVIDED) TO THE OPTIFLUX 160NR DIALYZER (DATE NOT PROVIDED). DURING INTAKE, THE PHYSICIAN WAS QUESTIONING WHY A SPECIFIC PATIENT WOULD EXPERIENCE A REACTION TO ELECTRON BEAM STERILIZATION AND NOT TO OTHER METHODS OF STERILIZATION. SUBSEQUENT ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION (E.G., PATIENT DEMOGRAPHICS, TREATMENT RECORDS, MEDICAL RECORDS) HAVE THUS FAR PROVEN UNSUCCESSFUL.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 11925487 ↗
• MalfunctionApr 3, 2019Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY REPORTED A DIALYZER BLOOD LEAK OCCURRED IMMEDIATELY AFTER THE INITIATION OF THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK WAS NOTED AS BEING IN THE EXTERNAL DIALYSATE INFLOW. THE LEAK WAS VISUALLY OBSERVED. BLOOD LEAK TEST STRIPS WERE NOT USED. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 250ML. 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 (NOT A FRESENIUS MACHINE) AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. IT WAS CONFIRMED THAT A SAMPLE IS NOT AVAILABLE FOR RETURN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8478022 ↗
• MalfunctionJul 17, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A USER FACILITY CLINIC MANAGER REPORTED AN OPTIFLUX 160NR DIALYZER THAT WAS FOUND TO HAVE A FOREIGN OBJECT INSIDE IT. THIS WAS DISCOVERED PRIOR TO USE, AND THERE WAS NO PATIENT INVOLVEMENT. THE CLINIC MANAGER ADVISED IT APPEARED THE FOREIGN OBJECT WAS ADDITIONAL FILTER MATERIAL. THE CLINIC MANAGER CONFIRMED THE DIALYZER WAS AVAILABLE TO BE RETURNED TO THE PLANT FOR INVESTIGATION.

  Patient problems: No Patient Involvement

  MAUDE report 7695465 ↗
• MalfunctionJun 26, 2018Fluid/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 EXTERNAL BLOOD LEAK, AND IT WAS VISUALLY OBSERVED AS A CRACK NEAR THE ARTERIAL SIDE OF THE DIALYZER. 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 250ML. 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 WAS 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 7639666 ↗
• MalfunctionNov 17, 2017Fluid/Blood Leak; Fluid/Blood Leak

  A HEMODIALYSIS (HD) CLINIC MANAGER REPORTED DURING HD TREATMENT THE MACHINE ALARMED OF A BLOOD LEAK DURING TREATMENT. BLOOD WAS NOTED COMING FROM THE ARTERIAL PORT OF THE DIALYZER INTO THE DIALYSATE. THE PATIENT'S TREATMENT WAS TERMINATED WITHOUT RETURNING THE PATIENT'S BLOOD. PATIENT EXPERIENCED GREATER THAN 100 ML OF BLOOD LOSS. ADDITIONAL FOLLOW-UP REVEALED THE PATIENT WAS CONNECTED TO THE 2008T HD MACHINE WHEN THE BLOOD LEAK WAS OBSERVED. THE 2008T HD MACHINE GENERATED A BLOOD LEAK ALARM APPROXIMATELY A MINUTE AFTER THE HD THERAPY WAS INITIATED. THE PATIENT¿S DIALYSATE FLOW RATE (DFR) WAS 600 AND THE PATIENT¿S BLOOD FLOW RATE (BFR) WAS 450. THE LEAK WAS NOTED AS BEING AN INTERNAL BLOOD LEAK WITHIN THE DIALYZER, AND NO EXTERNAL LEAK WAS NOTED. NO DAMAGE TO THE DIALYZER OR PACKAGING WAS OBSERVED. BLOOD WAS VISUALLY NOTED AND A BLOOD LEAK TEST STRIP WAS NOT USED. NO PATIENT ADVERSE EFFECTS WERE EXPERIENCED AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT WAS ABLE TO COMPLETE TREATMENT WITH NEW SUPPLIES ON ANOTHER MACHINE WITHOUT ISSUE. THE PATIENT DIALYZED 3 TIMES A WEEK. THE SAMPLE WAS DISCARDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7041025 ↗
• MalfunctionNov 3, 2017Fluid/Blood Leak; Fluid/Blood Leak

  CLINIC NURSE REPORTED A DIALYZER BLOOD LEAK ONE HOUR INTO PATIENT'S TREATMENT. DURING FOLLOW UP A CLINIC NURSE REPORTED THAT THE PATIENT DID NOT REQUIRE ANY MEDICAL INTERVENTION AND WAS MOVED TO ANOTHER MACHINE TO COMPLETE DIALYSIS. THE MACHINE ALARMED AND BLOOD WAS VISIBLE IN THE DIALYSATE. NO TEST STRIP WAS USED. THE BLOOD LOSS WAS APPROXIMATELY 200 CC OR ONE COMPLETE CIRCUIT. THE DIALYZER WAS NOT MADE AVAILABLE FOR EVALUATION.

  Patient problems: Blood Loss

  MAUDE report 7001137 ↗
• DeathOct 12, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A BIOMEDICAL ENGINEER (BIOMED TECH) REPORTED AN ADVERSE EVENT OCCURRED DURING HEMODIALYSIS TREATMENT ON (B)(6) 2017. ADDITIONAL FOLLOW-UP REVEALED A PATIENT EXPIRED WHILE DIALYZING. PER BIOMED TECH, THE MACHINE DID NOT HAVE ANY ISSUES DURING SET-UP AND THAT THE MACHINE DID NOT ALARM AT THE TIME THE PATIENT EXPIRED. (B)(6) STATED NO MACHINE REPAIRS WERE NEEDED AND THE MACHINE WAS PLACED BACK IN SERVICE. THE BIOMED TECH STATED THE FACILITY ALSO USED FRESENIUS 2008T HEMODIALYSIS MACHINES, FRESENIUS DIALYZERS, BLOODLINES, ACID CONCENTRATE DELIVERED VIA JUGS. ADDITIONAL FOLLOW-UP WAS MADE WITH THE CLINIC MANAGER, WHO REVEALED THE PATIENT EXPIRED WHEN HE WAS NEAR THE END OF HEMODIALYSIS TREATMENT AT THE BEGINNING OF THE RINSE BACK PROCESS. THE CLINIC MANAGER DECLINED TO HAVE A FRESENIUS RES COME OUT FOR MACHINE EVALUATION. THE CLINIC MANAGER STATED THE PATIENT¿S CAUSE OF DEATH WAS CARDIAC ARREST, AND INDICATED THE PATIENT HAD PRE-EXISTING CARDIAC RELATED ISSUES AS WELL AS METASTATIC CANCER. THE CLINIC MANAGER STATED THE PATIENT WAS HOSPITALIZED THE WEEK PRIOR DUE TO CARDIAC RELATED ISSUES, AND INDICATED THE PATIENT BEGAN HIS FIRST HEMODIALYSIS TREATMENT WHILE HOSPITALIZED ON (B)(6) 2017,

  Patient problems: Cardiac Arrest; Death

  MAUDE report 6944960 ↗
• MalfunctionSep 13, 2017Fluid/Blood Leak; Fluid/Blood Leak

  A CLINIC MANAGER REPORTED A PATIENT WAS CONNECTED TO THE 2008T HD MACHINE WHEN A BLOOD LEAK WAS OBSERVED FROM THE DIALYZER. THE 2008T HD MACHINE GENERATED A BLOOD LEAK ALARM APPROXIMATELY 30 MINUTES AFTER THE HD THERAPY WAS INITIATED. THE PATIENT¿S DIALYSATE FLOW RATE (DFR) WAS 175 AND THE PATIENT¿S BLOOD FLOW RATE (BFR) WAS 350. THE MANAGER STATED THE BLOODLINES USED WERE FRESENIUS. THE LEAK WAS NOTED AS BEING AN INTERNAL BLOOD LEAK WITHIN THE DIALYZER, AND NO EXTERNAL LEAK WAS NOTED. NO DAMAGE TO THE DIALYZER OR PACKAGING WAS OBSERVED. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS UNKNOWN. THE MANAGER STATED A BLOOD LEAK TEST STRIP WAS USED AFTER THE INCIDENT TO CHECK FOR THE PRESENCE OF BLOOD IN THE DIALYSATE; THE TEST STRIP RETURNED A POSITIVE RESULT. PER CLINIC MANAGER NO PATIENT ADVERSE EFFECTS WERE EXPERIENCED AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT DIALYZED 3 TIMES A WEEK AND HAD BEEN ON HEMODIALYSIS SINCE (B)(6) 2017. THE PATIENT WAS ABLE TO COMPLETE TREATMENT WITH NEW SUPPLIES ON ANOTHER MACHINE. THE MANAGER STATED THE SAMPLE WAS DISCARDED AND WAS NO LONGER AVAILABLE FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6860876 ↗