BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3133836 · Received May 29, 2013

    Report

    Report Number
    1416980-2013-13481
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 4, 2013
    Report Date
    May 4, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVALUATION WAS COMPLETED ON THE RETURNED DEVICE. A VISUAL INSPECTION AND FUNCTIONAL TESTS WERE PERFORMED. THE DEVICE WAS DETERMINED TO MEET FUNCTIONAL AND ELECTRICAL PERFORMANCE SPECIFICATION REQUIREMENTS. THE REPORTED ISSUE WAS DETERMINED TO BE DUE TO ONE OR MORE CYCLE ADVANCES TO THE NEXT FILL WHEN SLOW / NO FLOW OCCURRED, ABOVE THE MIN DRAIN VOLUME THRESHOLD. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4).THE DEVICE WAS RETURNED TO BAXTER AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. THE REVIEW OF THE EVENT LOG HAS CONFIRMED THE REPORTED PROBLEM. HOWEVER, THE ROOT CAUSE OF THE ALARM HAS NOT YET BEEN DETERMINED. A SUPPLEMENAL REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOMECHOICE DEVICE EXPERIENCED A HIGH DRAIN ALARM. THE ALARM OCCURRED AFTER THE PATIENT HAD COMPLETED THERAPY. THERE WAS PATIENT INVOLVEMENT; HOWEVER, NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237121 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR