BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSION PUMP

    MDR report key: 2861368 · Received November 30, 2012

    Report

    Report Number
    MW5027954
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    November 30, 2012
    Report Date
    November 30, 2012
    Manufacturer
    ABBOTT LABORATORIES INC
    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

    PT CONTROLLED ANALGESIC INFUSION PUMP WAS SET TO INFUSION DILAUDID 2MG PER HOUR AND 2MG EVERY 15MIN PER PROTOCOL. PUMP WAS SET UP AND VERIFIED BY 2 RNS. PUMP MALFUNCTIONED AND INFUSED ENTIRE MEDICATION IN 3.5 HOURS. RAPID RESPONSE WAS CALLED SO THAT PT COULD BE FURTHER ASSESSED. THREE DOSES OF THE MEDICATION NARCAN WAS ADMINISTERED TO REVERSE THE DILAUDID. THERE WAS NO HARM TO THE PT. PT-CONTROLLED ANALGESIC INFUSION PUMP DATE PURCHASED (B)(6) 2003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSION PUMP PT CONTROLLED ANALGESIC INFUSION PUMP MEA ABBOTT LABORATORIES INC 4100

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other