BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAXTER

    MDR report key: 316020 · Received February 2, 2001

    Report

    Report Number
    MW1021060
    Event Type
    Injury
    Date Received
    February 2, 2001
    Date of Event
    January 29, 2001
    Report Date
    February 1, 2001
    Manufacturer
    BAXTER HEALTHCARE CORP. RENAL PRODUCT SVC
    Product Code
    FIR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE RENAL BLOOD PUMP, CONTINUOUS RENAL REPLACEMENT THERAPY, SHOWED CODES C-21, E-23, TECHNICAL CODE SHOWS CHECK LIGHT ON EVERY 1-2 MINS. BAXTER TECHNICIAN SUPPORT REPLACED CURRENT BOARD, AND RECALIBRATED THE MACHINE BUT THE MACHINE FAILED TO FUNCTION. THE PT WAS PLACED ON CONVENTIONAL DIALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4257 BAXTER BLOOD MONITOR FIR BAXTER HEALTHCARE CORP. RENAL PRODUCT SVC BMLLA *

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention