BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    MDR report key: 1863969 · Received October 11, 2010

    Report

    Report Number
    1423500-2010-04290
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    September 17, 2010
    Report Date
    September 17, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    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). EVALUATION SUMMARY: THE DEVICE WAS RECEIVED OPERATIONAL AND PASSED RETURN INSTRUMENT TEST / EVALUATION (RITE) ELECTRICAL SPECIFICATION TEST, BUT FAILED RITE FUNCTIONAL TEST FOR DRAIN 1 VOLUME (822.3 ML). THE RITE FUNCTIONAL TEST FAILED DRAIN 1 WAS CONFIRMED BY REVIEW OF THE RITE FUNCTIONAL TEST REPORT. THE CAUSE WAS UNDETERMINED. THE PRODUCT ANALYSIS LAB (PAL) PERFORMED A METHOD 3 EVALUATION. ACCURACY CONFIRMATION AND TEMPERATURE VERIFICATION TESTS WERE PERFORMED AND PASSED. THE RITE FAILURE WAS NOT DUPLICATED DURING THE METHOD 3 EVALUATION. THE DEVICE LOGS WERE REVIEWED AND THERE WERE NO VOLUMES THAT MET THE CURRENT CRITERIA OF AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) INCIDENT. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ISSUES RELATED 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 HAS BEEN RECEIVED, AND THE EVALUATION IS IN PROCESS. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    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: THERAPY MONITORED VOLUME FAILED PERFORMANCE SPECIFICATION FAILING DRAIN 1. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR