BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCLAIM ENCORE

    MDR report key: 1060804 · Received June 12, 2008

    Report

    Report Number
    2921482-2008-00185
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    May 15, 2008
    Report Date
    May 20, 2008
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K991501
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE PT RECEIVED LESS IV FLUID THAN INTENDED. AT AN UNSPECIFIED TIME THE PUMP WAS PROGRAMMED TO DELIVER 5% DEXTROSE AND NORMAL SALINE AT A RATE OF 80ML/HR, WITH A VOLUME TO BE INFUSED (VTBI) OF 960ML AND THE DELIVERY WAS INITIATED. AT AN UNSPECIFIED TIME, THE PUMP DISPLAY INDICATED THE DELIVERY WAS COMPLETE: HOWEVER, THE NURSE NOTED 200ML REMAINED IN THE CONTAINER WHEN IT WAS EXPECTED TO BE "ALMOST EMPTY." AT AN UNSPECIFIED TIME, THE CONTAINER WAS REPLACED AND THE THERAPY WAS RESUMED. AFTER 12 HOURS, THE NURSE NOTED THE DISPLAY INDICATED THE DELIVERY WAS COMPLETE; HOWEVER, 200ML REMAINED IN THE CONTAINER WHEN IT WAS EXPECTED TO BE "ALMOST EMPTY". THE PUMP WAS REMOVED FROM CLINICAL SERVICE. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCLAIM ENCORE 80-FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR