BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3220920 · Received July 11, 2013

    Report

    Report Number
    1416980-2013-18049
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    May 16, 2013
    Report Date
    June 17, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING THE EVENT HISTORY LOG REVIEW, AN INCREASED INTRA-PERITONEAL VOLUME EVENT WAS IDENTIFIED. THE ROOT CAUSE OF THE REPORTED ISSUE WAS DETERMINED TO BE 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 REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF ANY RELEVANT INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE MACHINE, ONE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED WHICH OCCURRED IN THE THERAPY INITIATED ON (B)(6) 2013 AT 20:56:34. DURING NIGHT DRAIN CYCLE FIVE, THE PATIENT'S ULTRAFILTRATION READING WAS 2029ML, INDICATING THE HOME PATIENT (HP) DRAINED 2029ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 2000ML. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321116 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR