BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CDI 540 CALIBRATOR

    MDR report key: 2052070 · Received March 1, 2011

    Report

    Report Number
    1828100-2011-00454
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    February 5, 2011
    Report Date
    March 1, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DRY
    PMA / PMN Number
    K972962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING PREPARATION OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THAT A "CF08" ERROR MESSAGE OCCURRED, AND THAT THE DEVICE FAILED TO PERFORM THE SHUNT SENSOR CALIBRATION. THE DEVICE WAS NOT USED, AND THE USER PERFORMED AN IN-VIVO CALIBRATION FOR THE PROCEDURE INSTEAD. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO A PT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO CDI 540 CALIBRATOR CALIBRATOR DRY TERUMO CARDIOVASCULAR SYSTEMS CORP. 540

    Patients

    Seq Age Sex Outcome Treatment
    1