BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMASOL BGK 4/2.5 CRRT BAG

    MDR report key: 11893221 · Received May 26, 2021

    Report

    Report Number
    MW5101568
    Event Type
    Malfunction
    Date Received
    May 26, 2021
    Date of Event
    May 24, 2021
    Report Date
    May 25, 2021
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KPO
    UDI-DI
    24571010506
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    CRRT BAGS NOT SECURELY SEALED BETWEEN THE PORTS, RESULTING IN BAG RUPTURE INSIDE THE PRODUCT OVERWRAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786430 PRISMASOL BGK 4/2.5 CRRT BAG DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) KPO BAXTER HEALTHCARE CORPORATION 24571010506

    Patients

    Seq Age Sex Outcome Treatment
    1