BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMAFLEX

    MDR report key: 19483547 · Received June 7, 2024

    Report

    Report Number
    19483547
    Event Type
    Malfunction
    Date Received
    June 7, 2024
    Date of Event
    September 30, 2023
    Report Date
    January 30, 2024
    Manufacturer
    GAMBRO LUNDIA AB
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PRIMSAFLEX PUMP (CIRCUIT LOT # 230047) WITH ODD ALARMS: "SET DISCONNECT" WHILE PUMP WAS RUNNING, VERY HIGH P DROP AND TMP PRESSURES IN THE 400S, ACCESS AND RETURN PRESSURES ALSO ALARMING. PATIENT REMAINED STABLE THROUGHOUT TROUBLESHOOTING ALARMS, CIRCUIT ENDED UP CLOTTING AND A NEW PRISMAFLEX MACHINE AND CIRCUIT WERE SET UP. THIS MACHINE WAS TAKEN OUT OF SERVICE, WORK REQUEST FILED. PATIENT WAS DISCHARGED. NO HARM IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1436651 PRISMAFLEX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI GAMBRO LUNDIA AB 230047

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Male