BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 4220138 · Received November 3, 2014

    Report

    Report Number
    1416980-2014-38449
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 8, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN EVENT INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE WAS IDENTIFIED. AS THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING FOR AN UNRELATED ALARM ON THE HOMECHOICE (HC) MACHINE, IT WAS REPORTED THAT THE HOME PATIENT (HP) OBSERVED AIR IN THE PATIENT LINE. THIS WAS NOTICED WHILE THE HP WAS CONNECTED TO THE SETUP. TROUBLESHOOTING FOR THE AIR IN LINE WAS THEN PERFORMED, AND NOTHING WAS FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE PRESENCE OF AIR. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HP CYCLE THE POWER ON THE HC DEVICE, CLOSE ALL THE CLAMPS, AND END THERAPY. THE TSR ADVISED THE HP TO START THERAPY OVER WITH NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700909 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR HOMECHOICE