BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3152688 · Received June 7, 2013

    Report

    Report Number
    1416980-2013-14646
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 29, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOMECHOICE (HC) DEVICE WAS RETURNED AND EVALUATED BY THE PRODUCT ANALYSIS LABORATORY (PAL). THE DEVICE PASSED THE HC RETURN INSTRUMENT TEST/EVALUATION RITE ELECTRICAL TEST BUT FAILED THE RITE FUNCTIONAL TEST DUE TO HEATER BAG TEMP TEST FAILED. THE UNIT WAS RECEIVED IN OPERATIVE AND IN GOOD CONDITION. AN EXTERNAL/INTERNAL INSPECTION WAS PERFORMED AND PASSED. DURING RITE FUNCTIONAL TESTING FLUID WAS BEING DELIVERED BELOW THE RITE TEMPERATURE SPECIFICATION. VOLUMETRIC ACCURACY TEST WAS PERFORMED AND FAILED. TEMPERATURE CONFIRMATION TESTING WAS PERFORMED AND PASSED. PERFORMED EVALUATION AND WHEN THE PUMP ASSEMBLY WAS ACTIVATED THERE WAS EXCESSIVE VIBRATING. THE VIBRATING NOISE WAS DETERMINED TO BE COMING FROM THE PUMP ASSEMBLY. INSPECTED DOOR ASSEMBLY AND FOUND INSUFFICIENT AMOUNT OF COPPER MESH AND CRACKED DOOR PISTON. DUE TO THE INSUFFICIENT AMOUNT OF COPPER MESH BEING INSTALLED THE UNIT COULD NOT DELIVER AN ACCURATE AMOUNT OF FLUID RESULTING IN VOLUMETRIC ACCURACY FAILURE. THE CAUSE FOR THE ISSUE OF VOLUMETRIC ACCURACY FAILURE WAS DETERMINED TO BE INSUFFICIENT AMOUNT OF COPPER MESH. THE PUMP ASSEMBLY AND DOOR PISTON WERE SCRAPPED. THE DEVICE WAS SENT TO SERVICING. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP WILL BE SUBMITTED.

    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
    252238 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1