BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUAL COOLER/HEATER

    MDR report key: 3851096 · Received February 12, 2014

    Report

    Report Number
    1828100-2014-00044
    Event Type
    Malfunction
    Date Received
    February 12, 2014
    Date of Event
    January 21, 2014
    Report Date
    January 21, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWC
    PMA / PMN Number
    PREAMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE COOLER HEATER UNIT TURNED OFF. THE PERFUSIONIST (CCP) TURNED THE DIAL TO RECIRCULATION FOR A FEW SECONDS AND THE UNIT POWERED BACK UP. THEN THE CCP TURNED THE DIAL BACK TO HEAT MODE. NO OTHER DETAILS REGARDING THE NATURE OF THIS EVENT WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93067 DUAL COOLER/HEATER SARNS DUAL COOLER/HEATER DWC TERUMO CARDIOVASCULAR SYSTEMS CORP. 11160

    Patients

    Seq Age Sex Outcome Treatment
    1