BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE-REFURBISHED

    MDR report key: 1081784 · Received July 18, 2008

    Report

    Report Number
    1423500-2008-00670
    Event Type
    Malfunction
    Date Received
    July 18, 2008
    Date of Event
    May 22, 2008
    Report Date
    July 1, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: THE HOMECHOICE MACHINE WAS REC'D AND EVALUATED. THREE SIMULATED PT THERAPIES WERE PERFORMED USING THE PT'S THERAPY SETTINGS. DURING THESE THERAPIES, NO PROBLEMS WERE ENCOUNTERED. THE DEVICE WAS TESTED FOR TEMPERATURE ACCURACY. NO FLUID TEMPERATURES WERE RECORDED THAT WERE OUTSIDE THE SPECIFIED DELIVERY RANGE. 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 AND WAS WITHIN DESIGN SPECIFICATIONS. THE DEVICE'S PNEUMATIC SYSTEM WAS MONITORED AND NO PROBLEMS WERE REVEALED; ALL PRESSURES WERE CORRECT AND STABLE. THE COVER WAS OPENED AND AN INTERNAL INSPECTION WAS PERFORMED. NO PROBLEMS WERE ENCOUNTERED AND ALL CONNECTIONS WERE CORRECT AND SECURE. A REVIEW OF THE DEVICE'S SERVICE HISTORY REVEALED NO ISSUES RELATED TO OVERFILL. NO FAILURE OR MALFUNCTION OF THE DEVICE WAS OBSERVED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY. BASED ON A REVIEW OF ALL AVAILABLE INFO, THE MOST PROBABLE CAUSE OF THIS OVERFILL WAS DETERMINED TO BE INSUFFICIENT DRAIN DUE TO A FALSE EMPTY DETECT AND A USE ERROR IN THAT INITIAL DRAIN ALARM SETTING WAS INAPPROPRIATELY PROGRAMMED. THE DEVICE WILL BE ROUTED TO THE SERVICE AREA.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE MACHINE, AN OVERFILL WAS IDENTIFIED. IN THE THERAPY SESSION STARTED IN '08, DRAIN 1, THE HOME PATIENT'S ULTRAFILTRATION (UF) READING WAS 1014 ML. THIS UF INDICATES THAT THE HOME PATIENT (HP) DRAINED 1014 ML MORE THAN THE PROGRAMMED FILL VOLUME OF 2500 ML FOR A TOTAL DRAIN OF 3514 ML. PRODUCT SURVEILLANCE SPOKE WITH THE HOME PATIENT'S NURSE REGARDING THE OVERFILL DISCOVERED. SHE STATED THAT THE PT NEVER REPORTED FEELING OVERFILLED OR ANY ADVERSE SYMPTOMS RELATED TO INCREASED INTRA-PERITONEAL VOLUME. THE NURSE CONFIRMED THAT THERE WAS NO PT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH OVERFILL FOR THIS PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE-REFURBISHED 76FKX FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1