BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3241987 · Received July 23, 2013

    Report

    Report Number
    1416980-2013-19391
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 27, 2013
    Report Date
    June 27, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REVIEW OF THE DEVICE LOGS DID NOT CONFIRM THE RITE FUNCTIONAL TEST FAILING. THE INTERNAL AND EXTERNAL INSPECTION OF THE DEVICE FOUND NO ISSUES. ALSO, THE DEVICE HAD PASSED THE SPECIFICATIONS FOR MANUAL TEMPERATURE TEST AND FOR THE RETURNED INSTRUMENT TEST/EVALUATION (RITE) ELECTRICAL SAFETY ANALYZER TEST. HOWEVER, THE DEVICE HAD FAILED EVALUATION (RITE) FUNCTIONAL TESTING DUE TO FAILED THERAPY MONITORED VOLUME. AS A RESULT, IT HAD FAILED A MANUAL VOLUMETRIC ACCURACY TEST. DURING THE INSPECTION OF THE DOOR PISTON, INSUFFICIENT AMOUNT OF COPPER MESH WAS FOUND. AS A RESULT, THE CAUSE FOR THE RITE FUNCTIONAL TEST FAILING WAS DETERMINED TO BE AN INSUFFICIENT AMOUNT OF COPPER MESH. THE DEVICE WAS SENT FOR SERVICING WHERE THE DOOR PISTON WAS DISCARDED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE (HC) DEVICE, A HC MACHINE FAILED THE RETURNED INSTRUMENT TEST/EVALUATION (RITE) FUNCTIONAL TESTING DUE TO THERAPY MONITORED VOLUME FAIL PERFORMANCE SPECIFICATION. DEVICE FAILED DURING EVALUATION; THEREFORE, NO PATIENT INVOLVED. ADDITIONAL INFORMATION IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343403 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1