BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUWAVE (3CC) VAMP 68 INCH PRESSURE MONITORING

    MDR report key: 8731022 · Received June 24, 2019

    Report

    Report Number
    MW5087584
    Event Type
    Injury
    Date Received
    June 24, 2019
    Date of Event
    June 19, 2019
    Report Date
    June 20, 2019
    Manufacturer
    EDWARD LIFESCIENCES LLC
    Product Code
    DXO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PRODUCT MALFUNCTION. EDWARD LIFESCIENCES PRESSURE MONITORING SET TRUWAVE (3CC) VAMP 68 INCH. WHILE ATTEMPTING TO FLUSH THE BLOOD BACK INTO THE PT AFTER A BLOOD DRAW, THE TUBING FROM THE VAMP BROKE OFF FROM THE VAMP SITE CAUSING BLOOD TO SPLASH OUT AND BLOOD TO BACK FLOW ONTO THE FLOOR. THE WHITE STOPCOCK WAS TURNED OFF IN FRONT OF THE VAMP TO PREVENT ANY FURTHER BLOOD LOSS. THE PT WAS CRITICAL AND NOW NEEDED NEW TUBING PRIMED AND CHANGE. NO COMPLICATION OCCURRED TO THE PT. PRODUCT WAS SAVED FOR INVESTIGATION. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523039 TRUWAVE (3CC) VAMP 68 INCH PRESSURE MONITORING TRANSDUCER, PRESSURE, CATHETER TIP DXO EDWARD LIFESCIENCES LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention