BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE PRO

    MDR report key: 2181837 · Received July 28, 2011

    Report

    Report Number
    1423500-2011-09868
    Event Type
    Death
    Date Received
    July 28, 2011
    Date of Event
    June 24, 2011
    Report Date
    July 14, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE PAL EVALUATED THE DEVICE AND NO FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) FOUND IN THE DEVICE LOGS. THE CAUSE OF THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) IDENTIFIED IN THE DEVICE LOG WAS DETERMINED TO BE INSUFFICIENT DRAIN, FALSE EMPTY DETECT AND USE ERROR, CLINICIAN INAPPROPRIATELY SET MINIMUM DRAIN VOLUME % SETTING TOO LOW. THIS ISSUE WAS CONFIRMED THROUGH REVIEW OF THE EVENT HISTORY LOG.

    Additional Manufacturer Narrative · 1

    (B)(4). ON (B)(6) 2011, DURING A CALL REGARDING A RETURNED HOMECHOICE (HC) DEVICE THE PATIENT'S NURSE STATED THAT THE PATIENT HAD DIED ON AN UNREPORTED DATE. THE CAUSE OF DEATH WAS NOT REPORTED. THE STATUS OF THE PATIENT'S HEALTH PRIOR TO THE DEATH WAS NOT REPORTED. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED PRIOR TO THE DEATH, IF REMEDIAL THERAPY WAS RENDERED, OR IF AN AUTOPSY WAS PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED, AND THE EVALUATION IS IN PROCESS. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    DURING INITIAL ASSESSMENT OF A RETURNED HOMECHOICE MACHINE, A BAXTER TECHNICIAN FOUND AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) THAT WAS IDENTIFIED IN PATIENT THERAPY LOG ON (B)(6) 2011 STARTED AT 03:02 WITH DRAIN VOLUME OF 4463 ML DURING CYCLE 4, LARGEST PRESCRIBED FILL VOLUME: 2500ML. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED. THIS EVENT MEETS OVERFILL CRITERIA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death