BEUDAMED
    FDA Adverse Event Summary report: N

    ALARIS

    MDR report key: 2875036 · Received November 12, 2012

    Report

    Report Number
    2875036
    Date Received
    November 12, 2012
    Date of Event
    November 6, 2012
    Report Date
    November 12, 2012
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    FRN
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT BROUGHT TO NUCLEAR MEDICINE FOR LEXISCAN STRESS TEST WITH RADIOISOTOPE. PATIENT HAD IV PUMP INFUSING IV FLUIDS. NUCLEAR MEDICINE TECH CLAMPED OFF TUBING, DID NOT FEEL RESISTANCE, AND BEGAN TO PUSH ISOTOPE AND THEN FLUIDS. PUMP STARTED ALARMING AND RN NOTED THAT DOOR TO PUMP WAS AJAR. SHE OPENED DOOR AND NOTED WATER BALLOON FORMATION OF TUBING AND THEN TUBING RUPTURED CAUSING RADIATION SPILL TO HER EYES, HANDS AND CLOTHING. MINIMAL SPILL ON PATIENT AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP, INFUSION FRN CAREFUSION 303, INC. 8015 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *