BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIPRO ELISIO-H DIALYZER

    MDR report key: 19107001 · Received April 15, 2024

    Report

    Report Number
    9610987-2024-00002
    Event Type
    Malfunction
    Date Received
    April 15, 2024
    Date of Event
    March 22, 2024
    Report Date
    August 30, 2024
    Manufacturer
    NIPRO CORPORATION (ODT)
    Product Code
    KDI
    PMA / PMN Number
    K131935
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    15 MINUTES INTO HDF DIALYSIS TREATMENT, STAFF NOTICED BLOODLEAK IN THE DIALYZER. MACHINE DID NOT ALARM FOR ANY ISSUES, ONLY VAM (VENOUS ACCES MONITOR) ALARM WAS NOTED. THE FACILITY TESTED FOR BLOOD LEAK AND RESULTS WERE POSITIVE. PROPHYLACTIC ANTIBIOTICS WERE ADMINISTED. PER FACILITY, PATIENT HAS BEEN USING THE ELISIO-H DIALYZERS FOR THE PAST 4 YEARS. THE PRIMING PROCEDURES WERE ACCORDING TO THE FRESENIUS MACHINE FOR ONLINE PRIMING. DIALYSIS SETTING SWERE HDF POST DILUTION. STILL PENDING ADDITIONAL INFORMATION FROM FACILITY.

    Description of Event or Problem · 0

    15 MINUTES INTO HDF DIALYSIS TREATMENT, STAFF NOTICED BLOODLEAK IN THE DIALYZER. MACHINE DID NOT ALARM FOR ANY ISSUES, ONLY VAM (VENOUS ACCES MONITOR) ALARM WAS NOTED. THE FACILITY TESTED FOR BLOOD LEAK AND RESULTS WERE POSITIVE. PROPHYLACTIC ANTIBIOTICS WERE ADMINISTERED. PER FACILITY, PATIENT HAS BEEN USING THE ELISIO-H DIALYZERS FOR THE PAST 4 YEARS. THE PRIMING PROCEDURES WERE ACCORDING TO THE FRESENIUS MACHINE FOR ONLINE PRIMING. DIALYSIS SETTING WERE HDF POST DILUTION. STILL PENDING ADDITIONAL INFORMATION FROM FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1509390 NIPRO ELISIO-H DIALYZER DIALYZER KDI NIPRO CORPORATION (ODT) DD+ELISIO-H 23G03P

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other