BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    MDR report key: 1940696 · Received December 17, 2010

    Report

    Report Number
    1828100-2010-02564
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 18, 2010
    Report Date
    December 17, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DRY
    PMA / PMN Number
    K972962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED, THE BLOOD GAS MONITOR GENERATED AN "F0A1" ARTERIAL MODULE INITIALIZATION FAILURE. THE USER ALSO REPORTED, THE MIDDLE SENSOR WAS BROKEN, AND THAT THE TIP HAD "POPPED" OFF DURING CLEANING OF THE DEVICE. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. SINCE THE EVENT OCCURRED AFTER USE OF THE DEVICE, THERE WAS NO PATIENT INVOLVEMENT DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO CDI 500 BLOOD PARAMETER MONITOR ON LINE BLOOD GAS MONITOR DRY TERUMO CARDIOVASCULAR SYSTEMS CORP. 500AHCT

    Patients

    Seq Age Sex Outcome Treatment
    1