BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO ADP SYSTEM

    MDR report key: 2209480 · Received August 8, 2011

    Report

    Report Number
    MW5021691
    Event Type
    Malfunction
    Date Received
    August 8, 2011
    Date of Event
    May 4, 2011
    Report Date
    August 8, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE BAXTER HOMECHOICE PRO ADP SYSTEM, SERIAL NUMBER (B)(4) WOULD NOT PRIME. BECAUSE THE UNIT WOULD NOT PRIME, IT WAS NEVER PLACED ON THE PATIENT. IT HAS PRIMED AND WORKED PROPERLY SEVERAL PREVIOUS USES. THE LABELING ON THE UNIT INDICATED IT HAD BEEN RECONDITIONED BY BAXTER HEALTHCARE CORP, (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE PRO ADP SYSTEM CYCLER FKX BAXTER HEALTHCARE HOMECHOICE PRO ADP

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO