BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO TCM II COOLING AND HEATING SYSTEM

    MDR report key: 2040836 · Received March 21, 2011

    Report

    Report Number
    1828100-2011-00687
    Event Type
    Malfunction
    Date Received
    March 21, 2011
    Date of Event
    February 23, 2011
    Report Date
    March 21, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWC
    PMA / PMN Number
    K883603
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING PREPARATION OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THAT THE PUMP DID NOT START WHEN FIRST TURNED ON. THE PUMP STARTED AFTER IT WAS TURNED OFF AND BACK ON, BUT THEN WAS MAKING A REALLY LOUD NOISE. THE DEVICE WAS USED FOR THE PROCEDURE. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO TCM II COOLING AND HEATING SYSTEM HEATING COOLING SYSTEM DWC TERUMO CARDIOVASCULAR SYSTEMS CORP. 4415

    Patients

    Seq Age Sex Outcome Treatment
    1