BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFECARE PCA

    MDR report key: 1063423 · Received June 19, 2008

    Report

    Report Number
    MW5007374
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Report Date
    June 19, 2008
    Manufacturer
    HOSPIRA
    Product Code
    MEA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    HOSPIRA LIFECARE PCA PUMP: OUR INTERNAL TESTING HAS FOUND THAT IF THE TUBING CLAMP IS INADVERTENTLY KEPT IN THE CLOSED POSITION AFTER PROGRAMMING, THE PUMP IS UNABLE TO SENSE THIS ERROR FOR WHAT MAY BE SEVERAL HOURS -DEPENDING ON THE FLOW RATE AND THE PRESENCE OR ABSENCE OF A CONTINUOUS INFUSION. WHEN THE CLAMP IS RELEASED, A BOLUS DOSE OF UP TO 2 ML IS RELEASED. HOSPIRA INFORMS US THAT THE MAXIMUM BOLUS TO THE PT IS CLOSER TO 0.9 ML. FOR A PATIENT USING MORPHINE 5 MG/ML, THIS COULD RESULT IN AN INADVERTENT BOLUS DOSE OF 4.5 MG. OBVIOUSLY, THERE WILL ALSO BE THE RISK OF INADEQUATE PAIN CONTROL DURING THIS PERIOD. FOR CERTAIN SENSITIVE PATIENTS, THIS BOLUS OF 4.5 MG OF MORPHINE COULD RESULT IN A SERIOUS ADVERSE DRUG EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFECARE PCA NONE MEA HOSPIRA

    Patients

    Seq Age Sex Outcome Treatment
    1