BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 3002363 · Received March 13, 2013

    Report

    Report Number
    1416980-2013-05994
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 21, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE FAILED RITE (RETURN INSTRUMENT TEST/EVALUATION) FUNCTIONAL TEST DUE TO RITE - THERAPY MONITORED VOLUME FAILED PERFORMANCE SPECIFICATIONS. THE DEVICE PASSED RITE ELECTRICAL TEST. THE CAUSE FOR THE REPORTED RITE ISSUE WAS DETERMINED TO BE DETERIORATED PISTON FOAM. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CURING EVALUATION OF A RETURNED HOMECHOICE (HC) DEVICE, A BAXTER TECHNICIAN DETERMINED THE HC MACHINE FAILED RITE (RETURN INSTRUMENT TEST/EVALUATION) FUNCTIONAL TEST DUE TO RITE - THERAPY MONITORED VOLUME FAILED PERFORMANCE SPECIFICATIONS. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106084 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1