BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3153489 · Received June 8, 2013

    Report

    Report Number
    1416980-2013-14618
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 13, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED; THEREFORE, A DEVICE ANALYSIS COULD NOT BE PERFORMED. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION. A DEVICE HISTORY REVIEW WAS PERFORMED FINDING NO EXCEPTION, NONCONFORMANCE, NOR REWORK THAT OCCURRED DURING THE MANUFACTURING OF THE DEVICE WITH THIS SERIAL NUMBER. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOME PATIENT (HP) HAD AN INCREASED INTRA-PERITONEAL VOLUME (IIPV). THIS HAD OCCURRED DURING DRAIN 4 OF 4, WHILE THE HP WAS CONNECTED. THE HP DRAINED 3221 ML AND THE HP'S FILL VOLUME HAD BEEN 2000 ML. THERE WAS PATIENT INVOLVEMENT, HOWEVER THERE WAS NO REPORT OF ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257746 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR HOMECHOICE AUTOMATED PD SET WITH CASSETTE