BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCLAIM ENCORE

    MDR report key: 652774 · Received September 21, 2005

    Report

    Report Number
    2921482-2005-00510
    Event Type
    Malfunction
    Date Received
    September 21, 2005
    Date of Event
    August 1, 2005
    Report Date
    August 29, 2005
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    "SPARKS" WERE NOTED FROM THE BOTTOM OF THE PUMP. THE PUMP WAS PROGRAMMED TO DELIVER TPN 1600 ML FOR A DURATION OF 12 HOURS OVERNIGHT, WITH A 1 HOUR TAPER UP AND A 1 HOUR TAPER DOWN. NO ADDITIONAL PROGRAMMING PARAMETERS WERE PROVIDED. AT 3:00 AM, THE PATIENT CALLED THE ON-CALL PHARMACIST TO REPORT THAT WHILE PLUGGED IN AND INFUSION, "SPARKS SHOT OUF OF THE BOTTOM" OF THE PUMP AND "THE BOTTOM WAS VERY HOT." THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THERAPY WAS RESUMED USING A REPLACEMENT DEVICE AT 5:00 PM THE FOLLOWING EVENING. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCLAIM ENCORE INFUSION PUMP FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other