BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOTHERM 400 CE

    MDR report key: 6895608 · Received September 26, 2017

    Report

    Report Number
    1516825-2017-00019
    Event Type
    Malfunction
    Date Received
    September 26, 2017
    Date of Event
    August 30, 2017
    Report Date
    September 26, 2017
    Manufacturer
    CINCINNATI SUB-ZERO, LLC.
    Product Code
    DWC
    PMA / PMN Number
    K122813
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    CSZ MEDICAL TECHNICAL SUPPORT RECEIVED A COMPLAINT STATING THE DEVICE WAS NOT MEETING THE SET POINT TEMPERATURE DURING A PROCEDURE. NO PATIENT HARM OR INJURY OCCURRED AND THE PROCEDURE CONTINUED SUCCESSFULLY. THE DEVICE WAS RETURNED TO CSZ FOR INVESTIGATION. CSZ FOUND THE 1250W HEATER TO BE INOPERATIVE. THE HEATER WAS REPLACED AND THE DEVICE FUNCTIONS AS DESIGNED.

    Description of Event or Problem · 1

    CINCINNATI SUB-ZERO MEDICAL TECHNICAL SUPPORT RECEIVED A COMPLAINT STATING THE DEVICE WAS NOT MEETING THE SET POINT TEMPERATURE DURING A PROCEDURE. NO PATIENT HARM OR INJURY OCCURRED AND THE PROCEDURE CONTINUED SUCCESSFULLY. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673465 HEMOTHERM 400 CE CARDIOPULMONARY BYPASS TEMPERATURE CONTROLLER DWC CINCINNATI SUB-ZERO, LLC. 400CE

    Patients

    Seq Age Sex Outcome Treatment
    1