BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREFUSION

    MDR report key: 1962613 · Received January 11, 2011

    Report

    Report Number
    MW5018991
    Event Type
    Malfunction
    Date Received
    January 11, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 11, 2011
    Manufacturer
    CAREFUSION/CARDINAL
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    DEVICE: CAREFUSION ALARIS INFUSION DEVICE. PT WAS RECEIVING BLOOD VIA ALARIS PUMP AT 120 ML/HR. RN TAKING CARE OF PT WAS AT LUNCH AND ANOTHER RN WAS COVERING. BLOOD WAS FOUND ON THE FLOOR DRIPPING FROM THE INSIDE OF THE PUMP. UPON OPENING, A TEAR WAS SEEN IN THE TUBING ABOVE THE SAFETY CLAMP. WE HAVE HAD MULTIPLE EVENTS RESULTING IN IV TUBING TEAR/RIP/MALFUNCTION WITH THIS DEVICE. UN-RELATED TO THIS ISSUE, THE PT EXPERIENCED A POSSIBLE BLOOD TRANSFUSION REACTION AND THE TUBING AND BLOOD HAD TO BE RETURNED TO BLOOD BANK. I WAS ASSISTING WITH PT DURING THIS TIME. EVENT ABATED AFTER USE: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAREFUSION ALARIS INFUSION PUMP FRN CAREFUSION/CARDINAL

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other