BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1001250 · Received February 12, 2008

    Report

    Report Number
    1423500-2008-00077
    Event Type
    Malfunction
    Date Received
    February 12, 2008
    Date of Event
    July 29, 2007
    Report Date
    January 15, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K012988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THREE STIMULATED PT THERAPIES WERE PERFORMED ON THE PT'S HOMECHOICE DEVICE USING THE PT'S THERAPY SETTINGS. DURING THESE THERAPIES, NO PROBLEMS WERE ENCOUNTERED. THE DEVICE WAS THEN TESTED FOR VOLUMETRIC ACCURACY. THIS TEST WAS PERFORMED AND THE FLUID VOLUME DELIVERED TO AND REMOVED FROM THE SIMULATED PT FOR EACH EXCHANGE WAS WITHIN DESIGN SPECIFICATIONS. SOFTWARE WAS THEN USED TO MONITOR THE DEVICE'S PNEUMATIC SYSTEM. NO PROBLEMS WERE REVEALED AND ALL PRESSURES WERE CORRECT AND STABLE. THE COVER WAS OPENED AND AN INTERNAL INSPECTION PERFORMED, NO PROBLEMS WERE REVEALED DURING THIS INSPECTION AND ALL CONNECTIONS WERE CORRECT AND SECURE. A REVIEW OF THE DEVICE SVC HISTORY REVEALED NO PAST TRENDS. THE EVENT LOG, THERAPY LOG, AND ALARM LOG WAS REVIEWED. THE EVENT LOG SHOWS THAT DURING INITIAL DRAIN ON ORIGINAL DATE, THE DEVICE ALARMED LOW DRAIN VOLUME AND WAS BYPASSED AFTER REMOVING 238ML OF A 2500ML LAST FILL. THE DEVICE THEN DELIVERED 2288ML OF A PROGRAMMED 2500ML FILL VOLUME. DWELL ONE WAS BYPASSED AND DRAIN ONE THEN REMOVED 4784ML. THE THERAPY LOG SHOWED THAT THE THERAPY ON THE SAME DAY, HAD TWO BYPASSES AND NO MANUAL DRAIN PERFORMED. A REVIEW OF THE DEVICE'S ALARM LOG SHOWS NO DEVICE ANOMALIES. THIS EVAL DID NOT CONFIRM ANY FAILURE OR MALFUNCTION OF THE DEVICE THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED OVERFILL. BASED ON A REVIEW OF ALL AVAILABLE THERAPY, ALARM AND EVENT LOG DATA, THE MOST PROBABLE CAUSE FOR THE OVERFILL WAS INSUFFICIENT DRAIN, FALSE EMPTY DETECT AND USER ERROR, OR INAPPROPRIATE BYPASS OF THE LOW DRAIN VOLUME ALARM.

    Description of Event or Problem · 1

    A HOME PT CONTACTED BAXTER'S TECHNICAL SVC CTR IN LATE 2007 REGARDING FEELING TOO FULL DURING PERITONEAL DIALYSIS THERAPY ON A HOMECHOICE DEVICE. DURING EVAL OF THE PT'S HOMECHOICE DEVICE, A BAXTER TECH IDENTIFIED AN ADD'L POTENTIAL OVERFILL SITUATION. DURING CYCLE TWO OF THERAPY OF FOUR MONTHS EARLIER, THE ULTRAFILTRATION (UF) WAS 837ML, INDICATING THAT THE PT DRAINED 837ML MORE THAN THE FILL VOLUME. THE FILL VOLUME WAS 2500ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE CYCLER-REFURBISHED 78FKX FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1