BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    MDR report key: 1900766 · Received November 16, 2010

    Report

    Report Number
    1423500-2010-05827
    Event Type
    Malfunction
    Date Received
    November 16, 2010
    Date of Event
    October 22, 2010
    Report Date
    October 22, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE PASSED THE HOMECHOICE RITE (RETURN INSTRUMENT TEST / EVALUATION) FUNCTIONAL TEST BUT FAILED THE RITE ELECTRICAL EARTH LEAKAGE CURRENT TEST. THE ASSIGNABLE CAUSE FOR RITE TEST FAILURE - EARTH LEAKAGE CURRENT WAS DETERMINED TO BE A DEFECTIVE PUMP. THE DEVICE'S SERVICE HISTORY RECORD WAS REVIEWED AND NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE RITE FAILURE. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE/SAMPLE HAS BEEN RECEIVED FOR EVALUATION AND A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 1

    DURING EVALUATION OF THE HOME CHOICE (HC) DEVICE, THE PRODUCT ANALYSIS LABORATORY DETERMINED THE HC MACHINE SYSTEM FAILED RETURNED INSTRUMENT TEST/EVALUATION TESTING DUE TO A FAILURE OF THE EARTH LEAKAGE CURRENT FAILED PERFORMANCE SPECIFICATION. DURING A CALL TO THE NURSE TO FOLLOW-UP ON THE HP, IT WAS REVEALED THAT THE HP HAD PASSED AWAY. ON (B)(6) 2010, WHILE HOSPITALIZED, THE PATIENT DIED. PER THE NURSE, THE FATAL EVENTS WERE UNRELATED TO DIANEAL THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4) 1.5% LO/CAL 5L/5L DIANEAL (B)(4) 2.5%