BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT LIFECARE PCA PUMP PLUS 2 MODEL

    MDR report key: 1803026 · Received August 12, 2010

    Report

    Report Number
    MW5017099
    Event Type
    Malfunction
    Date Received
    August 12, 2010
    Date of Event
    May 29, 2010
    Report Date
    August 12, 2010
    Manufacturer
    ABBOTT
    Product Code
    MEA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) PT IN THE ACUTE CARE HOSPITAL FOR CONTINUOUS MORPHINE AND INPATIENT HOSPICE DUE TO HEART FAILURE. CASSETTE WAS SET AT 0.5 MG PER HOUR BUT RAN IN 6 HOURS FOR A TOTAL OF 30 MG. BASICALLY RUNNING AT 5.0 MG PER HOUR INSTEAD OF 0.5 MG PER HOUR. PT WAS GIVEN NARCAN, NO HARM TO THE PT, PUMP TAGGED OUT OF SERVICE. PUMP SETTING WAS VERIFIED BY MULTIPLE PEOPLE AND WAS SET CORRECTLY AT 0.5 MG PER HOUR. STAFF DID NOT DOCUMENT MODEL OR SERIAL NUMBER IN THE REPORT, SO WE HAVE NO IDEA WHICH DEVICE IT WAS -BIO MEDICAL ENGINEERING WOULD RECEIVE AND SERVICE ALL PUMPS IN THE HOSPITAL. DATES OF USE: (B)(6) 2010 - (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: PCA PUMP. EVENT ABATED AFTER USE: YES. EVENT REAPPEARED AFTER REINTRODUCTION: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT LIFECARE PCA PUMP PLUS 2 MODEL PCA PUMP MEA ABBOTT PLUS 2

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other