BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSURE MONITORING KIT WITH TRUWAVE DISPOSABLE TRANSDUCER

    MDR report key: 1951344 · Received December 20, 2010

    Report

    Report Number
    1951344
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    October 7, 2010
    Report Date
    December 20, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DRS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RN ENTERED THE ROOM AND FOUND PATIENT BLEEDING FROM ARTERIAL LINE. APPROXIMATELY 100 ML BLOOD ON THE SHEETS. ARTERIAL LINE BECAME DISCONNECTED AT THE TRANSDUCER LEVEL, VAMP SITE. THE DISCONNECTION IS NOT A LUER LOCK SITE AND NOT A SITE THAT SHOULD EVER BE DISCONNECTED. IMMEDIATELY THE LINE WAS REMOVED AND CHANGED. THE SAME THING OCCURRED TWO TIMES LATER HOWEVER THESE DISCONNECTIONS OCCURRED WHILE PRIMING THE LINE.====================== HEALTH PROFESSIONAL'S IMPRESSION======================BLEEDING ARTERIALLY OCCURRED SOLELY DUE TO THE LINE DISCONNECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESSURE MONITORING KIT WITH TRUWAVE DISPOSABLE TRANSDUCER TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR DRS EDWARDS LIFESCIENCES * 58908230

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES