BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 3073533 · Received April 23, 2013

    Report

    Report Number
    1416980-2013-10160
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 5, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING EVALUATION OF A RETURNED HOMECHOICE (HC) DEVICE, A BAXTER TECHNICIAN DETERMINED THE HC MACHINE FAILED THE RETURN INSTRUMENT TEST/EVALUATION (RITE) EARTH LEAKAGE CURRENT TEST. (B)(4). THE PRODUCT ANALYSIS LAB (PAL) EVALUATED THE DEVICE. INTERNAL AND EXTERNAL INSPECTION REVEALED DAMAGE MARKS ON THE POWER SWITCH RESULTING IN IT'S BEING STUCK IN THE ON POSITION. THE CAUSE OF THE EARTH LEAKAGE CURRENT TEST FAILURE WAS EXTERNAL FORCE OR IMPACT. THE POWER SWITCH WILL BE REPLACED. DEVICE WAS SENT TO SERVICE. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE (HC) DEVICE, A BAXTER TECHNICIAN DETERMINED THE HC MACHINE FAILED THE EARTH LEAKAGE CURRENT TEST. DEVICE FAILED DURING EVALUATION, NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175284 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1