BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    MDR report key: 1881443 · Received October 25, 2010

    Report

    Report Number
    1423500-2010-04876
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 2, 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 HAS BEEN RECEIVED BY BAXTER, HOWEVER THE EVALUATION HAS NOT BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE FAILED THE HOMECHOICE RITE (RETURN INSTRUMENT TEST / EVALUATION) FUNCTIONAL TEST FOR HEATER BAG TEMPERATURE TEST. ACCURACY CONFIRMATION AND TEMPERATURE VERIFICATION TESTS WERE PERFORMED AND PASSED. THE CAUSE FOR RITE TEST FAILURE - HEATER BAG TEMPERATURE TEST WAS UNDETERMINED. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE FAILURE. 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 THE HOMECHOICE (HC) DEVICE, THE PRODUCT ANALYSIS LABORATORY DETERMINED THE HC MACHINE SYSTEM FAILED RETURNED INSTRUMENT TEST/EVALUATION TESTING DUE TO THE FOLLOWING FAILURE: HEATER BAG TEMPERATURE FAILED PERFORMANCE SPECIFICATION AS THE FLUID DELIVERED WAS OUT OF SPECIFICATION. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE PATIENT'S DIALYSIS PRODUCTS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED. NO FURTHER INFORMATION WAS PROVIDED. THE PRODUCT ANALYSIS LABORATORY (PAL) DETERMINED THE HC MACHINE SYSTEM FAILED RITE (RETURNED INSTRUMENT TEST/EVALUATION) TESTING DUE TO A(N) (INDICATE WHICH RITE STEP FAILED): HEATER BAG TEMP FAILED PERF SPEC-FLUID DELIVERED OUT OF SPEC. (B)(4).

    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