BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFECARE PCA PLUS INFUSER

    MDR report key: 280119 · Received May 26, 2000

    Report

    Report Number
    2921482-2000-00093
    Event Type
    Injury
    Date Received
    May 26, 2000
    Date of Event
    April 26, 2000
    Report Date
    April 28, 2000
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MEA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REPORT REC'D FROM ABBOTT INTERNATIONAL AFFILIATE (ABBOTT/CANADA) REPORTING AN OVERDELIVERY. ACCORDING TO THE REPORT: "OVERDELIVERY OF MORPHINE COINCIDENT WITH PCA PUMP. PT EXPERIENCED A DECREASE IN BLOOD PRESSURE AS A RESULT OF THE OVERDELIVERY...UPON SETTLING PT POST-OP, PCA PUMP WAS DOUBLE CHECKED BY 2 RN'S. PCA WAS PROGRAMMED IN RR (RECOVERY ROOM). LINE WAS NOT CLAMPED. PT HAD NOT USED PUMP, 0 READINGS, SYRINGE READ 0 ABSORBED. PCA EXPLAINED TO PT. PT PUSHED PCA BUTTON 1X, 3ML DELIVERED, SYRINGE CHECKED - 7.5 ML DELIVERED. PCA CLAMPED AND BUTTON TAKEN AWAY FROM PT. BLOOD PRESSURE DECREASED, PULSE DECREASED, O2 DECREASED 84% ON ROOM AIR. DR. PAGED, ORDERS RECEIVED, PHARMACY NOTIFIED. WHEN PHYSICIAN CALLED, POST-OP PT WAS PRESCRIBED SUPPLEMENTAL O2 AND PCA DISCONTINUED. MORPHINE VIAL WAS 2 MG/ML. PT HOSPITALIZATION WAS NOT PROLONGED AS RESULT OF INCIDENT." THERE WERE NO PCA PROGRAMMING PARAMETERS REPORTED, ONLY MORPHINE CONCENTRATION. THERE WAS NO ADDITIONAL INFO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFECARE PCA PLUS INFUSER INFUSION PUMP MEA ABBOTT LABORATORIES NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Life Threatening| R