BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOTHERM

    MDR report key: 7548585 · Received May 29, 2018

    Report

    Report Number
    7548585
    Event Type
    Malfunction
    Date Received
    May 29, 2018
    Date of Event
    May 8, 2018
    Report Date
    May 22, 2018
    Manufacturer
    CINCINNATI SUB-ZERO PRODUCTS, INC.
    Product Code
    DWC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING REWARMING, UNIT WAS FUNCTIONING PROPERLY. WHEN PATIENT REACHED 37 DEGREES, THE UNIT STOPPED CIRCULATING WATER AND THE PATIENT COOLED DOWN TO 36 DEGREES. THE SECOND UNIT WAS RETASKED TO WARM THE PATIENT TO 37 DEGREES. THIS REQUIRED A TOTAL OF 25 MINUTES OF ADDITIONAL BYPASS TIME. MANUFACTURER RESPONSE FOR HEATER COOLER, CINCINNATI SUB ZERO HEATER COOLER (PER SITE REPORTER): CINCINNATI SUB ZERO REPRESENTATIVE CONSULTED RE: THE EQUIPMENT. SPEAKING WITH TECH SUPPORT, HE DETERMINED THAT THE POWER BOARD WAS THE ISSUE. THE PUMP FUSE HAD BLOWN. WE RECEIVED THE NEW BOARD, INSTALLED IT, AND RAN IT FOR SEVERAL HOURS IN THE BIOMED SHOP. OUR EMPLOYEE THEN COMPLETED THE PREVENTATIVE MAINTENANCE ON IT BEFORE RETURNING IT TO SERVICE. NO FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391082 HEMOTHERM CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC CINCINNATI SUB-ZERO PRODUCTS, INC. 400CE

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR ANESTHESIA MACHINE, IV PUMPS, CINCINNATI HEATER CO