BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1000303 · Received February 14, 2008

    Report

    Report Number
    1423500-2008-00083
    Event Type
    Malfunction
    Date Received
    February 14, 2008
    Date of Event
    October 8, 2007
    Report Date
    January 17, 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

    (B)(4): TWO SIMULATED PT THERAPIES WERE PERFORMED ON THE HOMECHOICE DEVICE USING THE PT'S THERAPY SETTINGS. DURING THESE THERAPIES NO PROBLEMS WERE ENCOUNTERED. DURING THE 3RD THERAPY THE DEVICE ALARMED WITH A SE 2044 (POSITIVE P TANK LOW). THE THERAPY WAS RESTARTED AND NO FURTHER 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 SERVICE HISTORY REVEALED NO PAST TRENDS. A REVIEW OF THE DEVICE LOGS FOND AN ADD'L POTENTIAL OVERFILL ON (B)(4) 2007. THIS EVALUATION DID NOT CONFIRM ANY FAILURE OR MALFUNCTION OF THE DEVICE THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY OF OVERFILL. BASED ON A REVIEW OF ALL AVAILABLE THERAPY, ALARM AND EVENT LOG DATA COMBINED WITH AVAILABLE DECISION TREE INFO, IT WAS DETERMINED THAT THE MOST PROBABLE CAUSE FOR THE REPORTED DIFFICULTY OF OVERFILL WAS INSUFFICIENT DRAIN, USER ERROR, INAPPROPRIATE BYPASS OF THE INITIAL DRAIN. THE LOGS DID NOT CONTAIN SUFFICIENT DATA TO DETERMINE PROBABLE CAUSE FOR THE ADD'L POTENTIAL OVERFILL ON (B)(4) 2007.

    Description of Event or Problem · 1

    A HOME PT CONTACTED BAXTER'S TECHNICAL SERVICE CENTER ON (B)(6) 2007 TO REPORT FEELING OVERFILLED DURING PERITONEAL DIALYSIS THERAPY ON A HOME CHOICE DEVICE. DURING EVALUATION OF THE PT'S HOMECHOICE, A BAXTER TECHNICIAN IDENTIFIED AN ADD'L POTENTIAL OVERFILL SITUATION. THE PT'S ULTRAFILTRATION (UF) FOR CYCLE 4 OF THERAPY ON (B)(6) 2007 WAS 716ML, INDICATING THAT THE PT DRAINED 716ML MORE THAN THE FILL VOLUME. THE FILL VOLUME WAS 2200ML.

    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