BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUWAVE DISPOSABLE PRESSURE TRANSDUCER W/ VAMP KIT

    MDR report key: 1013232 · Received March 12, 2008

    Report

    Report Number
    6000002-2008-06161
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    February 7, 2008
    Report Date
    February 7, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ARTERIAL LINE BACKED UP BLOOD INTO THE RESERVOIR AND PUSHED THE RESERVOIR PLUNGER BACK TO ABOUT THE 1 ML MARK. PROBLEM PERSISTED DESPITE THE ASSURANCE THAT THE PLUNGER WAS FULLY SEATED AND LINES FLUSHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUWAVE DISPOSABLE PRESSURE TRANSDUCER W/ VAMP KIT DISPOSABLE PRESSURE MONITOR AND BLOOD SAMPLING SYSTEM DRS EDWARDS LIFESCIENCES PXVJ0711 58444156

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN