BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 3081778 · Received April 29, 2013

    Report

    Report Number
    1416980-2013-10613
    Event Type
    Malfunction
    Date Received
    April 29, 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
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INTERNAL AND EXTERNAL INSPECTIONS WERE PERFORMED AND PASSED. VOLUMETRIC ACCURACY TEST WAS PERFORMED AND THE DEVICE FAILED. TEMPERATURE CONFIRMATION TESTING WAS PERFORMED AND THE TEMPERATURE WAS VERIFIED TO BE WITHIN SPECIFICATION. INSPECTED DOOR ASSEMBLY AND FOUND DETERIORATED PISTON FOAM. THE CAUSE FOR THE RITE FAILURE OF FAILED VOLUME TRANSFERRED COMPARISON WAS DETERMINED TO BE THE DETERIORATED PISTON FOAM. THE PISTON FOAM WAS SCRAPPED, AND THE DEVICE WAS SENT TO SERVICE.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE (HC) DEVICE, A BAXTER TECHNICIAN DETERMINED THE HC MACHINE FAILED FLUID VOLUME ACCURACY TESTING. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184016 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1