BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX®

    MDR report key: 25068947 · Received May 4, 2026

    Report

    Report Number
    MW5187562
    Event Type
    Malfunction
    Date Received
    May 4, 2026
    Date of Event
    April 28, 2026
    Report Date
    April 28, 2026
    Manufacturer
    FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ATTEMPTED TO INITIATE HEMODIALYSIS TREATMENT WITH LINES CONNECTED TO PATIENT. BLOOD PULLED INTO DIALYZER WITH IMMEDIATE BLOOD LEAK ALARM. BLOOD WAS VISIBLE WITHIN THE DIALYSATE COMPARTMENT OF THE DIALYZER. BLOOD NOT RETURNED. ESTIMATED BLOOD LOSS 82 MLS. DIALYZERS WITH SAME LOT NUMBER FOUND TO HAVE CRACKS AND WERE PULLED AND SENT BACK TO DISTRIBUTION AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471038 OPTIFLUX® DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC 25PU04011

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Male