BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSPAC IV DISPOSABLE PRESSURE TRANSDUCER

    MDR report key: 2032690 · Received March 22, 2011

    Report

    Report Number
    2032690
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    March 19, 2011
    Report Date
    March 22, 2011
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    DRS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING ARTERIAL LINE CHANGE, WHEN THE RN TRIED TO TIGHTEN THE TRANSDUCER, THE STOPCOCKS BROKE OR WERE BROKEN ON THE TRANSPAC IV MONITORING KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSPAC IV DISPOSABLE PRESSURE TRANSDUCER TRANSDUCER DRS ICU MEDICAL, INC. * 2076364

    Patients

    Seq Age Sex Outcome Treatment
    1 *