BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL HEALTH

    MDR report key: 2415074 · Received January 9, 2012

    Report

    Report Number
    MW5023796
    Event Type
    Malfunction
    Date Received
    January 9, 2012
    Date of Event
    January 1, 2012
    Report Date
    January 9, 2012
    Manufacturer
    CARDINAL HEALTH
    Product Code
    MEA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT'S IV PUMP CHANNEL STARTED BEEPING AND SAID 'EMERGENCY SHUT DOWN?'. IV PUMP AND TUBING NOTED TO BE WET. PUDDLE OF IV FLUID ON THE FLOOR. TUBING REMOVED FROM CHAMBER AND NOTED TO BE LEAKING AND HAD A HOLE. PULMONARY ARTERY CATHETER SET UP IMMEDIATELY CHANGED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDINAL HEALTH ALARIS PC PUMP CHANNEL MEA CARDINAL HEALTH 10938662

    Patients

    Seq Age Sex Outcome Treatment
    1 12 DA