BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    MDR report key: 2182628 · Received July 5, 2011

    Report

    Report Number
    1828100-2011-01901
    Event Type
    Malfunction
    Date Received
    July 5, 2011
    Date of Event
    June 10, 2011
    Report Date
    July 5, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DRY
    PMA / PMN Number
    K972962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING PREPARATION OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THAT THE HOLDER BRACKET WAS TOO BIG. THE DEVICE WOULD NOT FIT ONTO BRACKET. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO CDI 500 BLOOD PARAMETER MONITOR CDI CABLE BRACKET DRY TERUMO CARDIOVASCULAR SYSTEMS CORP. CDI519

    Patients

    Seq Age Sex Outcome Treatment
    1