BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SYSTEM 115 VOLT (REFURBISHED)

    MDR report key: 407019 · Received July 17, 2002

    Report

    Report Number
    1423500-2002-00864
    Event Type
    Malfunction
    Date Received
    July 17, 2002
    Date of Event
    June 25, 2002
    Report Date
    June 25, 2002
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    SPOUSE OF HOME PT (HP) REPORTED THE BAXTER HOMECHOICE CYCLER MAY NOT HAVE DRAINED ENOUGH FLUID OFF OF HP DURING INITIAL DRAIN CYCLE. HP STARTED THERAPY WITH A 3 LITER FILL AND ONLY DRAINED 11 CC IN THE INITIAL DRAIN AND CYCLER THEN PROCEEDED TO FILL 1 OF 3. HP'S FILL VOLUME IS 2801 ML. BAXTER OPERATIONAL SUPPORT REPRESENTATIVE (OSR) ASSISTED HP INTO A MANUAL DRAIN AND WHEN HP REACHED 1392 ML THE DRAINING PROCESS WAS VERY SLOW. THE OSR HAD SPOUSE CHECK FOR ANYTHING THAT MAY BE CAUSING THE DRAIN PROCESS TO BE SLOW. OSR HAD HP SIT UP AND THE DRAINING PROCESS IMPROVED. THE FINAL DRAIN AMOUNT WAS 6235 ML, OSR HAD HP CONTINUE WITH TREATMENT AND ADVISED THEM TO CONTACT HEALTHCARE PROFESSIONAL (HCP) REGARDING THIS EVENT. HP DENIED EXPERIENCING ANY SHORTNESS OF BREATH OR FEELINGS OF BEING OVERFILLED. HP WAS COMFORTABLE. SPOUSE OF HP REPORTED NO MEDICAL INTERVENTION WAS NECESSARY AND NO PT INJURY RESULTED FROM THIS EVENT, HCP CONFIRMED THIS REPORT. OSR DID DISCOVER DEVICE INITIAL DRAIN ALARM IS SET TO THE "OFF" POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SYSTEM 115 VOLT (REFURBISHED) HOMECHOICE FKX BAXTER HEALTHCARE CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN