BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SARNS COOLER/HEATER

    MDR report key: 44783 · Received October 23, 1996

    Report

    Report Number
    1828100-1996-00003
    Event Type
    Malfunction
    Date Received
    October 23, 1996
    Date of Event
    September 23, 1996
    Report Date
    October 23, 1996
    Manufacturer
    3M HEALTH CARE SARNS AND CDI PRODUCTS.
    Product Code
    DWC
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AS THE PT WAS BEING REWARMED DURING CARDIOPULMONARY BYPASS, THE UNIT DID NOT STOP HEATING AT THE EXPECTED TEMPERATURE OF 30 DEGREE CELSIUS, RESULTING IN THE DELIVERY OF 45 DEGREE CELSIUS WATER TO THE PT. AT THIS TIME, THE UNIT WAS SWITCHED OUT. BOTH THE USER AND THE CO SERVICE REP WERE UNABLE TO DUPLICATE THIS PROBLEM. THE HIGHEST TEMPERATURE THAT WAS MEASURED ON THE PT DURING THE EVENT WAS 25 DEGREE CELSIUS. NO PT INJURY HAS BEEN REPORTED AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SARNS COOLER/HEATER COOLING HEATING DEVICE DWC 3M HEALTH CARE SARNS AND CDI PRODUCTS. 98-0702-0030-2 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention