BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSPAC

    MDR report key: 3062563 · Received April 9, 2013

    Report

    Report Number
    3062563
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    March 15, 2013
    Report Date
    April 9, 2013
    Manufacturer
    ICU MEDICAL, INC
    Product Code
    DRS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON AT LEAST THREE OCCASIONS, THE TRANSPAC IV TUBING "SNAPPED" AT THE CONNECTION JUST PROXIMAL TO THE FLUSH ADAPTOR LEAVING THE MALE CONNECTOR PORTION WITHIN THE FEMALE. THE TUBING WAS UNDER PRESSURE, HOWEVER STAFF REPORT THE PRESSURE BAG WAS NOT OVER-INFLATED AT THE TIME OF EITHER INCIDENT. WHEN THE TUBING SEPARATED IT CREATED THE POTENTIAL FOR AN "OPEN" SYSTEM (UNLESS EITHER OF THE TWO DISTAL STOPCOCKS WERE TURNED OFF TO THE PATIENT). IT ALSO ALLOW FLUID, UNDER PRESSURE, TO SATURATE THE SURROUNDING AREA UNLESS THE ROLLER CLAMP WAS QUICKLY CLOSED. THE REMAINING KITS, WITH THE SAME LOT NUMBER, WERE REMOVED FROM STOCK AND NO FURTHER INCIDENTS HAVE BEEN REPORTED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?THE SPECIFIC SURGERY INFORMATION WAS NOT REPORTED.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144517 TRANSPAC TRANSDUCER, BLOOD PRESSURE, EXTRAVASCULAR DRS ICU MEDICAL, INC 42584-05 2613339

    Patients

    Seq Age Sex Outcome Treatment
    1 *