BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3092601 · Received May 3, 2013

    Report

    Report Number
    1416980-2013-11262
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 12, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND EVALUATED BY THE PRODUCT ANALYSIS LAB (PAL). THE PAL EVALUATED THE DEVICE FOR THE ISSUE OF FAILED HOMECHOICE (HC) RETURN INSTRUMENT TEST/EVALUATION (RITE) FAILED FUNCTIONAL TEST FOR RITE - THERAPY MONITORED VOLUME FAILED PERFORMANCE SPECIFICATION. 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. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP MEDWATCH 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 FLUID VOLUME ACCURACY TESTING. DEVICE FAILED DURING EVALUATION, NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194099 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1