BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOTHERM 400CE

    MDR report key: 8262599 · Received January 18, 2019

    Report

    Report Number
    1516825-2019-00001
    Event Type
    Malfunction
    Date Received
    January 18, 2019
    Report Date
    January 18, 2019
    Manufacturer
    CINCINNATI SUB-ZERO PRODUCTS, LLC
    Product Code
    DWC
    PMA / PMN Number
    K122813
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE RETURNED FOR EVALUATION. SERVICE EVALUATION CONFIRMED THE HEATER WAS DEFECTIVE. THE HEATER WAS REPLACED TO CORRECT.

    Additional Manufacturer Narrative · 1

    THE PERFUSIONIST NOTICED THAT THE DEVICE WAS NOT HEATING THE PATIENT PROPERLY. THERE WERE NO ALARMS (AUDIBLE OR VISUAL) THAT INDICATED THE DEVICE WAS NOT HEATING. THE PERFUSIONIST CHANGED THE DEVICE OUT AND THE PROCEDURE CONTINUED WITHOUT INCIDENT. THE HEATER WAS REPLACED, WHICH CORRECTED THE PROBLEM AND THEN A FULL P.M. OF THE DEVICE WAS CONDUCTED. THERE WERE NOT FURTHER ISSUES WITH THE DEVICE NOTED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE DEVICE WAS NOT HEATING DURING A PROCEDURE. DEVICE WAS SWITCHED OUT AND PROCEDURE CONTINUED WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53632 HEMOTHERM 400CE CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC CINCINNATI SUB-ZERO PRODUCTS, LLC 400CE

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown