BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMP TCM II COOLING AND HEATING SYSTEM

    MDR report key: 3896490 · Received May 16, 2014

    Report

    Report Number
    1828100-2014-00443
    Event Type
    Malfunction
    Date Received
    May 16, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 24, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWC
    PMA / PMN Number
    K883603
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS DETERMINED BY TECHNICAL SUPPORT TO BE A FAULTY PRIME PSI SWITCH. TECHNICAL SUPPORT GAVE THE CUSTOMER, IN AN EMAIL, THE PART NUMBER OF THE PRIME PSI SWITCH AND THE PRICE, ALONG WITH THE INSTRUCTIONS ON HOW TO CHANGE THE SWITCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE COOLER HEATER UNIT DEVELOPED A PRIME FAULT. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO DELAYS, NO BLOOD LOSS, OR ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294603 TERUMP 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