BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMAFLEX

    MDR report key: 15282575 · Received August 24, 2022

    Report

    Report Number
    15282575
    Event Type
    Malfunction
    Date Received
    August 24, 2022
    Date of Event
    August 3, 2022
    Report Date
    August 3, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) PRIMSMA FLEX COULD NOT COMPLETE INITIAL ZERO OF PRODUCT SCALES FOR OPERATION. AFTER 2ND TRY, SCREEN SAID TO CUT OFF MACHINE AND CONTACT SERVICE PROVIDER TO CLEAR ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434166 PRISMAFLEX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION 7.XX

    Patients

    Seq Age Sex Outcome Treatment
    1 27740 DA Male