BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1880151 · Received October 22, 2010

    Report

    Report Number
    1423500-2010-04793
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 4, 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). THE PAL (PRODUCT ANALYSIS LAB) EVALUATED THE DEVICE. THE DEVICE WAS RECEIVED OPERATIONAL AND IN GOOD CONDITION. THE DEVICE FAILED THE HOMECHOICE RITE (RETURN INSTRUMENT TEST / EVALUATION) FUNCTIONAL TEST FOR VOLUMETRIC ACCURACY DURING FILL 1, DRAIN 1, FILL 2 & DRAIN 2, BUT PASSED THE RITE ELECTRICAL TEST. THE PAL EVALUATED THE DEVICE. THE DEVICE FAILED THE ACCURACY CONFIRMATION TEST. THE PNEUMATIC SYSTEM WOULD NOT PRESSURIZE AND A LOUD BUZZING NOISE COULD BE HEARD FROM WITHIN THE DEVICE. A VISUAL INSPECTION REVEALED THE DOOR PISTON WAS CRACKED IN SEVERAL LOCATIONS. THE ASSIGNABLE CAUSE FOR THE RITE TEST FAILURE - VOLUMETRIC ACCURACY DURING FILL 1, DRAIN 1, FILL 2 & DRAIN 2, WHICH WAS ASSESSED AS A REPORTABLE MALFUNCTION, WAS DETERMINED TO BE A CRACKED PISTON. 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.

    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 THE DEVICE MAY DELIVER INACCURATE FLUID VOLUME LEADING TO UNDER OR OVERFILL DURING FILL 1, FILL 2, DRAIN 1, AND DRAIN 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE CYCLER-REFURBISHED SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1