BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 2964740 · Received February 15, 2013

    Report

    Report Number
    1416980-2013-04006
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 1, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT WAS CONFIRMED. THE CAUSE OF THE USE ERROR WAS UNDETERMINED. THIS REPORT OF USE ERROR WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION THEREFORE NO FURTHER INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED GLOBAL TECHNICAL SERVICE DUE TO A SYSTEM ERROR 2240 (AIR IN TUBING), AND DURING TROUBLESHOOTING THE PATIENT STATED THAT SHE HAD REUSED THE SAME SUPPLIES AFTER THE ALARM IN AN ATTEMPT TO START THERAPY OVER. THE PATIENT HAD CONNECTED TO THE REUSED SUPPLIES. THE TECHNICAL SERVICES REPRESENTATIVE THEN HAD THE PATIENT END THERAPY SO THAT SHE COULD START OVER WITH ALL NEW SUPPLIES, AND REFERRED HER TO HER ON CALL NURSE FOR FURTHER MEDICAL INSTRUCTIONS. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68184 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE