BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3142416 · Received June 3, 2013

    Report

    Report Number
    1416980-2013-14065
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 16, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOMECHOICE (HC) DEVICE WAS RETURNED AND EVALUATED BY THE PRODUCT ANALYSIS LAB (PAL). THE DEVICE FAILED VOLUMETRIC ACCURACY TESTING. EXTERNAL/INTERNAL INSPECTION WAS PERFORMED AND PASSED. A VOLUMETRIC ACCURACY TEST WAS PERFORMED AND THE DEVICE FAILED. TEMPERATURE CONFIRMATION TESTING WAS PERFORMED AND THE TEMPERATURE WAS VERIFIED TO BE WITHIN SPECIFICATION. AN INSPECTION OF THE DOOR ASSEMBLY REVEALED THE DOOR PISTON FOAM DETERIORATED. THE CAUSE FOR THE FAILED VOLUMETRIC ACCURACY TEST WAS DETERMINED TO BE DETERIORATED DOOR PISTON FOAM. PAL RECOMMENDS REPLACING THE DOOR PISTON FOAM (2 EACH). THE DEVICE WAS SENT TO SERVICE.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244926 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1