BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    MDR report key: 1880181 · Received October 22, 2010

    Report

    Report Number
    1423500-2010-04791
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 5, 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). DEVICE EVALUATION EXPECTED BUT NOT YET COMPLETED. ANY ADDITIONAL INFORMATION OR RESULTS OF EVALUATION WILL BE PROVIDED IN A FOLLOW UP E MDR.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RECEIVED OPERATION AND IN GOOD CONDITION BY THE PAL (PRODUCT ANALYSIS LAB). THE DEVICE FAILED THE HOMECHOICE RITE (RETURN INSTRUMENT TEST / EVALUATION) FUNCTIONAL AND FAILED THE RITE ELECTRICAL EARTH LEAKAGE CURRENT TEST. THE PAL EVALUATED THE DEVICE. AN INTERNAL INSPECTION REVEALED FLUID INSIDE THE BOTTLE, DOOR AND PUMP ASSEMBLIES. THE ASSIGNABLE CAUSE FOR RITE TEST FAILURE - EARTH LEAKAGE CURRENT WAS DETERMINED TO BE A SHORTED PUMP DUE TO FLUID INGRESS. 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.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE (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 TEST.

    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