BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO TCM II COOLING AND HEATING SYSTEM

    MDR report key: 3831971 · Received March 7, 2014

    Report

    Report Number
    1828100-2014-00136
    Event Type
    Malfunction
    Date Received
    March 7, 2014
    Date of Event
    February 12, 2014
    Report Date
    February 13, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWC
    PMA / PMN Number
    K883603
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL SUPPORT SUGGESTED TO REPLACE THE CARDIOPLEGIA SENSOR. THE BIOMED IS REPAIRING THE UNIT AT THE HOSPITAL AND IS NOT REQUESTING SERVICE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE CARDIOPLEGIA DID NOT COOL LOW ENOUGH. THE USER FACILITY'S BIOMEDICAL ENGINEER (BIOMED) REPORTED WHEN HE CHECKED THE UNIT ON (B)(6) 2014, THE CARDIOPLEGIA DISPLAY READ 28 DEGREES CELSIUS AND THE OUTPUT LINE IN THE SMALL TANK READ 14.1 DEGREES CELSIUS. THE DEVICE WAS NOT CHANGED OUT. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO DELAYS, NO BLOOD LOSS, OR NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139066 TERUMO TCM II COOLING AND HEATING SYSTEM TCM II COOLING AND HEATING SYSTEM DWC TERUMO CARDIOVASCULAR SYSTEMS CORP. 4415

    Patients

    Seq Age Sex Outcome Treatment
    1