BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYCLER 220 VOLT HOMECHOICE PROAUTOMATED PD

    MDR report key: 1071505 · Received July 2, 2008

    Report

    Report Number
    1423500-2008-00585
    Event Type
    Malfunction
    Date Received
    July 2, 2008
    Date of Event
    May 26, 2008
    Report Date
    May 26, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K012988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE HOMECHOICE (HC) MACHINE WAS RECEIVED AND EVALUATED BY BAXTER. THE MACHINE PASSED A ONE HOUR THERAPY SESSION WITH NO ERRORS. THE HC PASSED ACCURACY TESTING. AN ELECTRICAL SAFETY TEST AND A FUNCTIONAL CHECK WERE COMPLETED AS REQUIRED. THE MOST PROBABLE CAUSE OF THE OVERFILL WAS DETERMINED TO BE THE HOME PATIENT BYPASSING THE INITIAL DRAIN CYCLE OF A TIDAL THERAPY AS WELL AS BYPASSING MANUAL DRAINS BEFORE THEY WERE COMPLETE.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED BAXTER TO REPORT FEELING OVERFULL AS THERAPY PROGRESSED WITH THE HOMECHOICE MACHINE. THE MAXIMUM FILL VOLUME THAT CAN BE PROGRAMMED IN THE MACHINE IS 3L. ALTHOUGH THE HP'S FILL VOLUME IS UNKNOWN, IT COULD NOT HAVE BEEN GREATER THAN 3 L. THE HP REPORTED SHE PERFORMED A MANUAL DRAIN AFTER A FEW CYCLES (SHE COULD NOT REMEMBER SPECIFICALLY HOW MANY CYCLES) AND DRAINED APPROXIMATELY 5.5 L OF SOLUTION, INDICATING AN OVERFILL. THE PATIENT REPORTED THAT IN HER PREVIOUS THERAPY SESSION, THE MACHINE WENT FROM THE DRAIN CYCLE TO THE FILL CYCLE WITHIN ONE MINUTE (ON MORE THAN ONE CYCLE). NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYCLER 220 VOLT HOMECHOICE PROAUTOMATED PD 78FKX FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1