BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFECARE PCA PLUS INFUSER

    MDR report key: 532883 · Received July 1, 2004

    Report

    Report Number
    2921482-2004-00386
    Event Type
    Injury
    Date Received
    July 1, 2004
    Date of Event
    December 1, 2003
    Report Date
    June 11, 2004
    Manufacturer
    HOSPIRA, INC.
    Product Code
    MEA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    GENERAL REPORT RECEIVED OF AN OVERDELIVERY. THE CUSTOMER CONTACT INDICATED THE EVENTS WERE THE RESULT OF AN OPERATOR ERROR IN PROGRAMMING THE DEVICES. THE CUSTOMER REPORTED THAT "SINCE 12/2003-04/2004 THERE WERE APPROXIMATELY 3 TO 4 INCIDENTS WHERE THE NURSES INCORRECTLY PROGRAMMED THE HYDROMORPHONE CONCENTRATION IN THE PUMP FOR 0.1 MG/DL INSTEAD OF THE INTENDED 1.0 MG/ML." SPECIFIC PT INFO, EVENT DETAILS, AND PUMP PROGRAMMING PARAMETERS WERE UNSPECIFIED. IT WAS REPORTED, "IN SOME CASES, THE PTS REQUIRED AN UNSPECIFIED DOSE OF NARCAN AND RECOVERED IMMEDIATELY." THERE WERE NO REPORTED ADVERSE PT SEQUELAE. THE CUSTOMER INDICATED THAT STAFF MEMBERS AT THE USER FACILITY WERE RE-EDUCATED ON THE CORRECT OPERATION OF THE DEVICE. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFECARE PCA PLUS INFUSER PCA INFUSION PUMP MEA HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Life Threatening| R HYDROMORPHONE, MANUFACTURER UNK.