BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 3961963 · Received July 28, 2014

    Report

    Report Number
    1416980-2014-24510
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    April 10, 2014
    Report Date
    July 3, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS EVALUATED AND THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) WAS IDENTIFIED IN THE REVIEW OF THE EVENT HISTORY LOGS. THE CAUSE WAS DETERMINED TO BE A FALSE EMPTY DETECT AND USE ERROR, CLINICIAN INAPPROPRIATELY SET MINIMUM DRAIN VOLUME PERCENT SETTING TOO LOW. THE HOMECHOICE APD SYSTEMS TRAINER'S GUIDE PROVIDES A WARNING "IF YOU SET THE MINIMUM DRAIN VOLUME % TOO LOW, AN INCOMPLETE DRAIN COULD RESULT FOR THE PATIENT. THIS COULD RESULT IN AN INCREASED INTRAPERITONEAL VOLUME (IIPV) SITUATION." A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE DEVICE, ONE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED WHICH OCCURRED IN THE THERAPY INITIATED ON (B)(6) 2014 22:06:10. DURING NIGHT DRAIN CYCLE FIVE, THE PATIENT'S ULTRAFILTRATION READING WAS 1132ML, INDICATING THE HOME PATIENT (HP) DRAINED 1132ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 1500ML. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438162 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1