BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUAL COOLER/HEATER

    MDR report key: 4110218 · Received September 10, 2014

    Report

    Report Number
    1828100-2014-00733
    Event Type
    Malfunction
    Date Received
    September 10, 2014
    Date of Event
    August 19, 2014
    Report Date
    August 19, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWC
    PMA / PMN Number
    PREAMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL IS IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PRE-CARDIOPULMONARY BYPASS, THE COOLER HEATER UNIT WAS NOT COOLING, IT JUST MELTS THE ICE. 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 PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559476 DUAL COOLER/HEATER SARNS DUAL COOLER/HEATER DWC TERUMO CARDIOVASCULAR SYSTEMS CORP. 11160

    Patients

    Seq Age Sex Outcome Treatment
    1