BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACCLAIM ENCORE

    MDR report key: 539636 · Received March 22, 2004

    Report

    Report Number
    2921482-2004-00163
    Event Type
    Other
    Date Received
    March 22, 2004
    Date of Event
    January 1, 2003
    Report Date
    March 12, 2004
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    FRN
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED OF A TUBING SET BEING LOADED INTO THE DEVICE BACKWARDS. THE PUMP WAS PROGRAMMED WITH UNSPECIFIED PROGRAMMING PARAMETERS. THE NURSE REPORTEDLY LOADED THE TUBING INTO THE PUMP BACKWARDS RESULTING IN FLUID BACKING UP INTO THE DRIP CHAMBER. THE NURSE DID NOT NOTE ANY BLOOD BACK-UP IN THE TUBING. THE CUSTOMER STATED, "IT WAS CAUGHT RIGHT AWAY WHEN THEY NOTICED THE DRIP CHAMBER WAS FULL." THE TUBING SET WAS REMOVED FROM THE PUMP, REINSERTED CORRECTLY, AND THERAPY RESUMED WITHOUT FURTHER INCIDENT. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCLAIM ENCORE INFUSION PUMP FRN ABBOTT LABORATORIES NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other