BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3162662 · Received June 11, 2013

    Report

    Report Number
    1416980-2013-14995
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 28, 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): DURING EVALUATION OF A RETURNED HOMECHOICE (HC) DEVICE, A BAXTER TECHNICIAN DETERMINED THE HC MACHINE FAILED THE EARTH LEAKAGE CURRENT TEST. THE PRODUCT ANALYSIS LABORATORY (PAL) EVALUATED THE DEVICE. THE DEVICE FAILED THE HC RETURN INSTRUMENT TEST/EVALUATION (RITE) ELECTRICAL TEST DUE TO EARTH LEAKAGE AND FAILED THE RITE FUNCTIONAL TEST DUE TO SYSTEM ERROR (SE) 2044. THE DEVICE WAS RECEIVED IN OPERATIVE AND IN GOOD CONDITION. AN EXTERNAL/INTERNAL INSPECTION WAS PERFORMED AND FAILED DUE TO FLUID INTRUSION. THE DEVICE POWERED UP PROPERLY THEN PERFORMED PRIMING SEQUENCE DURING WHICH SE2044 OCCURRED. CRT (CYCLER REMOTE TOOLBOX) PNEUMATIC SYSTEM WAS PERFORMED AND THE PUMP ASSEMBLY DID NOT ACTIVATE. VOLTAGE VERIFICATION AT J3 (PUMP ASSEMBLY) ON THE ACCOMP PCB AND THE PUMP ASSEMBLY HAD VOLTAGE SUPPLIED HOWEVER THE PUMP ASSEMBLY DID NOT ACTIVATE. VOLTAGE VERIFICATION WAS PERFORMED ON THE DIGITAL PCB AND VOLTAGES WERE FOUND TO BE WITHIN SPECIFICATION. EVALUATION WAS TERMINATED DUE TO FLUID INTRUSION AND NO TEST ARTICLE COULD BE USED DUE TO POSSIBLE CONTAMINATION OF EQUIPMENT. THE CAUSE FOR THE EARTH LEAKAGE WAS DETERMINED TO BE CAUSED BY A MALFUNCTIONING PUMP ASSEMBLY DUE TO FLUID INTRUSION. THE DEVICE WAS TO BE SCRAPPED. THIS COMPLAINT IS RELATED TO (B)(4). IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP 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 THE EARTH LEAKAGE CURRENT TEST. DEVICE FAILED DURING EVALUATION, NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262624 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1