BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HX2 TEMPERATURE MANAGEMENT SYSTEM

    MDR report key: 4110121 · Received September 11, 2014

    Report

    Report Number
    1828100-2014-00745
    Event Type
    Malfunction
    Date Received
    September 11, 2014
    Date of Event
    August 20, 2014
    Report Date
    August 21, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWC
    PMA / PMN Number
    K071521
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE REPRESENTATIVE (FSR) FOUND THE USER DID NOT HAVE ENOUGH CHLORINE IN THE WATER WHEN HE TESTED THE UNIT. THE FSR SPOKE WITH THE PERFUSIONIST (CCP) ABOUT THE CHLORINE LEVELS. NO PARTS BEING RETURNED FOR EVALUATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THERE WERE WATER LEVEL ALARMS ON BOTH CHANNELS OF THE HEATER COOLER UNIT. THE FRONT PANEL LIGHT CAME ON (RED LIGHT WITH WATER BUCKET ICON). AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. 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
    563133 HX2 TEMPERATURE MANAGEMENT SYSTEM HX2 TEMPERATURE MANAGEMENT SYSTEM DWC TERUMO CARDIOVASCULAR SYSTEMS CORP. 809810

    Patients

    Seq Age Sex Outcome Treatment
    1