BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3831105 · Received May 23, 2014

    Report

    Report Number
    1416980-2014-16914
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    March 24, 2014
    Report Date
    May 1, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). "THE DEVICE HAS BEEN RECEIVED BY BAXTER AND IS IN THE PROCESS OF BEING EVALUATED. UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED."

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE DEVICE, AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED WHICH OCCURRED IN THE THERAPY INITIATED ON (B)(6) 2014 AT 21:50:54. DURING NIGHT DRAIN CYCLE FOUR, THE PATIENT'S ULTRAFILTRATION READING WAS 1560ML, INDICATING THE HOME PATIENT (HP) DRAINED 1560ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 2500ML. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308118 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR TRANSFER SET, CASSETTE