BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3132393 · Received May 29, 2013

    Report

    Report Number
    1416980-2013-13522
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 5, 2013
    Report Date
    May 5, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS NOT AVAILABLE FOR EVALUATION. THEREFORE, THE REPORTED CONDITION COULD NOT BE CONFIRMED, AND THE ROOT CAUSE COULD NOT BE DETERMINED. SHOULD THE DEVICE OR ANY ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE AIR BUBBLES IN THE PATIENT LINE OF A PERITONEAL DIALYSIS (PD) SET WITH CASSETTE. THIS OCCURRED DURING THE INITIAL DRAIN CYCLE OF PD THERAPY. THE TECHNICAL SERVICES REPRESENTATIVE ADVISED THE PATIENT TO START THERAPY OVER WITH NEW SUPPLIES. THERE WAS NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234960 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR HOMECHOICE