BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT PAIN MGR

    MDR report key: 559642 · Received December 13, 2004

    Report

    Report Number
    2921482-2004-00746
    Event Type
    Injury
    Date Received
    December 13, 2004
    Date of Event
    November 22, 2004
    Report Date
    November 23, 2004
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED FROM AN INTERNATIONAL AFFILIATE OF AN OVERDELIVERY. THE PRESCRIPTION AND ADMINISTRATION RECORD DATED 2004, UNSPECIFIED TIME INDICATED THE PUMP PROGRAMMING PARAMETERS AS PCA ONLY MODE, WITH A DRUG CONCENTRATION OF 0.5MG/ML, NO LOADING DOSE, A 2MG PCA DOSE, A 5 MINUTE PT LOCKOUT, 100ML TOTAL VOLUME, AND A 4 HOUR LIMIT OF 30MG. THE REPORT STATES, "THE PT WAS TRANSFERRED BACK TO THE WARD AT 1600 IN SATISFACTORY CONDITION, BREATHING AT ROOM AIR, COMPLAINING OF FEELING VERY ITCHY. AT 1615, THE PT COMPLAINED ABOUT BREATHING DIFFICULTY AND THEIR EXTREMITIES WERE BLUE. PT WAS THEN GIVEN PHENERGAN. AT 1630, PT WENT INTO RESPIRATORY ARREST, AND STATS CHECKED 38%. THE PT WAS TREATED WITH NARCAN TO AID BREATHING, AND 100% OXYGEN COMMENCED. THE PT WAS TRANSFERRED TO THE SURGICAL ICU AND PUMP WAS RESTARTED. DR SAID THAT PERHAPS MORHPHINE DOSE WAS TOO HIGH AND A NEW LOWER DOSE WAS PROGRAMMED IN. THE PT WAS, TREATED FOR MORPHINE OVERDOSE AS NURSE SUSPECTED THAT THE PUMP OVER-DELIVERED. DR SAID THAT THE PUMP WAS FINE BUT NURSING MANAGER REPORTED PUMP. THE SAME PUMP WAS USED ON PT ONCE MOVED TO ICU. THE PT'S CONDITION IMPROVED." THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Life Threatening| R MORPHINE, DIPRAVAN, FLAGYL, ULTIVA, PROSTIGMINE,| MANUFACTURERS UNK.| ROBINUL, CEFRIL, NIMBEX, TORADOL, AND REMICAINE,