BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3053053 · Received April 11, 2013

    Report

    Report Number
    1416980-2013-09040
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 29, 2013
    Report Date
    March 29, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND EVALUATED BY THE PRODUCT ANALYSIS LAB (PAL). THE PAL EVALUATED THE DEVICE FOR THE ISSUE OF FAILED HOMECHOICE (HC) RETURN INSTRUMENT TEST/EVALUATION (RITE) FAILED FUNCTIONAL TEST FOR RITE - THERAPY MONITORED VOLUME FAILED PERFORMANCE SPECIFICATION. THE VOLUMETRIC ACCURACY WAS PERFORMED AND DEVICE FAILED THE FIRST TEST WITH ORIGINAL PISTON FOAM, PASSED THE SECOND TEST WITH PAL TEST ARTICLE PISTON FOAM INSTALLED AND THEN FAILED THE THIRD TEST WITH ORIGINAL PISTON FOAM REINSTALLED INTO THE PISTON. THE DEVICE PASSED TEMPERATURE VERIFICATION. EXTERNAL AND INTERNAL INSPECTION WERE PERFORMED AND REVEALED NO PROBLEMS. THE DEVICE WAS CONNECTED TO THE PC TESTER VIA CONNECTOR J1 ON THE BACK OF THE DEVICE. THE FTC AND CRT COMMANDS WERE EXECUTED SEVERAL TIMES AND NO PROBLEMS ENCOUNTERED. THE CRT VERIFIED THAT THE DEVICE PNEUMATIC SYSTEM FUNCTIONED NORMALLY. DEVICE PASSED THE SEAL, PURGE AND WET DISPOSABLE INTEGRITY TESTS AND SUCCESSFULLY COMPLETED A SHORT SIMULATED THERAPY. AN INSPECTION WAS PERFORMED ON THE DOOR AND PISTON. THIS INSPECTION REVEALED THE PISTON FOAM WAS DISINTEGRATED. THE CAUSE WAS DETERMINED TO BE DISINTEGRATED PISTON FOAM. SCRAP PISTON FOAM. THE DEVICE WAS SENT TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER DISCONTINUED USE OF THE HOMECHOICE (HC) MACHINE AND RETURNED IT TO BAXTER (B)(4). THE PRODUCT ANALYSIS LABORATORY (PAL) DETERMINED THE HC MACHINE SYSTEM FAILED RITE (RETURNED INSTRUMENT TEST/EVALUATION) TESTING DUE TO A RITE - THERAPY MONITORED VOLUME FAILED PERFORMANCE SPEC. RITE TEST FAILURE FOUND BY SERVICE PERSONNEL DURING EVALUATION, NO PATIENT INVOLVED. AFTER REVIEW OF THE (B)(4) SYSTEM, THE CUSTOMER DISCONTINUED USE OF THE DEVICE DUE TO: TRANSPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154415 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1