BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT PAIN MANAGER II

    MDR report key: 460075 · Received May 9, 2003

    Report

    Report Number
    2921482-2003-00241
    Event Type
    Other
    Date Received
    May 9, 2003
    Date of Event
    April 15, 2003
    Report Date
    April 15, 2003
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    FRN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED OF A PROGRAMMING ERROR RESULTING IN A PATIENT RECEIVING 10MG OF DILAUDID INSTEAD OF THE INTENDED 8MG LIMIT. THE PHYSICIAN ORDERS WERE FOR PCA PLUS CONTINUOUS MODE, WITH A 0.2MG/ML CONCENTRATION. THE SETTINGS WERE A CONTINUOUS RATE OF 1ML/HR, PCA DOSE OF 1ML, NO LOADING DOSE AND AN 8ML 1-HOUR LIMIT. APPROXIMATELY 24 HOURS AFTER THE INFUSION WAS INITIATED A NURSE NOTED THAT THE PUMP HAD INADVERTENTLY BEEN PROGRAMMED FOR A 10ML 1-HOUR LIMIT. THE PATIENT HAD RECEIVED AN EXTRA 2ML OF DILAUDID. THE PHYSICIAN'S ORDERS WERE CLARIFIED AND THE NURSE CHANGED THE 1-HOUR LIMIT TO 8ML. THE REPORTER STATED THAT THE INFUSION WAS RESUMED FOR ANOTHER 24 HOURS. THERE WAS NO IMPACT TO THE PATIENT AND NO INTERVENTION WAS REQUIRED. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT PAIN MANAGER II INFUSION PUMP FRN ABBOTT LABORATORIES NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other