BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CDI 540 CALIBRATOR

    MDR report key: 1900555 · Received October 29, 2010

    Report

    Report Number
    1828100-2010-01905
    Event Type
    Malfunction
    Date Received
    October 29, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 29, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DRY
    PMA / PMN Number
    K972962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING PREPARATION FOR USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THAT THE BALL BEARING WAS "GUMMED UP", WHICH PREVENTED THE CABLE HEAD FROM FITTING INTO THE CALIBRATOR. THE DEVICE WAS USED FOR THE PROCEDURE. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO A PATIENT 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