BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1030291 · Received April 15, 2008

    Report

    Report Number
    1423500-2008-00246
    Event Type
    Malfunction
    Date Received
    April 15, 2008
    Date of Event
    February 3, 2008
    Report Date
    March 26, 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

    THE RETURNED HOMECHOICE MACHINE WAS EVALUATED IN THE PRODUCT ANALYSIS LABORATORY (PAL). THREE SIMULATED PT THERAPIES WERE PERFORMED USING THE PT'S THERAPY SETTINGS. DURING THESE THERAPIES, NO PROBLEMS WERE ENCOUNTERED. THE DEVICE'S PNEUMATIC SYSTEM WAS EVALUATED AND NO PROBLEMS WERE REVEALED. ALL PRESSURES WERE CORRECT AND STABLE. THE COVER WAS OPENED AND AN INTERNAL INSPECTION WAS PERFORMED. NO PROBLEMS WERE REVEALED AND ALL CONNECTIONS WERE CORRECT AND SECURE. A REVIEW OF THE DEVICE SERVICE HISTORY REVEALED NO PAST TRENDS. REVIEW OF THE MACHINE'S EVENT LOG AND CYCLE BY CYCLE ULTRAFILTRATION (UF) LOG, AN OVERFILL WAS DISCOVERED IN DRAIN 6 OF THE THERAPY STARTED ON 02/03/08. BASED ON A REVIEW OF ALL AVAILABLE DATA THE MOST PROBABLE CAUSE FOR THE OVERFILL WAS DETERMINED TO BE INSUFFICIENT DRAIN WHEN MULTIPLE CYCLES ADVANCED TO FILL WHEN A SLOW/NO FLOW CONDITION OCCURRED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD. THE PAL DID NOT CONFIRM ANY FAILURE OR MALFUNCTION OF THE DEVICE THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY. THE HOMECHOICE MACHINE WILL BE ROUTED TO THE SERVICE AREA FOR REFURBISHMENT.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE MACHINE, IT WAS DISCOVERED IN THE LOGS THAT IN DRAIN 6 OF THE THERAPY SESSION STARTED IN 2008, THE ULTRAFILTRATION (UF) READING WAS 1286. THE PATIENT'S PROGRAMMED FILL VOLUME IS 2000 ML. THIS UF READING INDICATES THE PT DRAINED 1286 ML MORE THAN THE PROGRAMMED FILL VOLUME FOR A TOTAL DRAIN OF 3286 ML. PRODUCT SURVEILLANCE PLACED A FOLLOW UP CALL TO THE HOME PATIENT REGARDING THE OVERFILL DISCOVERED DURING EVALUATION. THE HOME PT DID NOT REMEMBER THERAPY ON THE DATE IN QUESTION AND COULD NOT PROVIDE ADDITIONAL DETAILS. HE DID NOT RECALL ANY ADVERSE EVENTS/SYMPTOMS ASSOCIATED WITH THE LARGE DRAIN VOLUMES REPORTED AND STATED HIS THERAPY IS GOING WELL. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT.

    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