BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUAL COOLER/HEATER

    MDR report key: 1890793 · Received November 1, 2010

    Report

    Report Number
    1828100-2010-01936
    Event Type
    Malfunction
    Date Received
    November 1, 2010
    Date of Event
    October 7, 2010
    Report Date
    November 1, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWC
    PMA / PMN Number
    PREAMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING PREVENTATIVE MAINTENANCE OF THE DEVICE, THE USER REPORTED THE HEATER COOLER LEAKED. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. SINCE THE EVENT OCCURRED DURING PREVENTATIVE MAINTENANCE, THERE WAS NO PT INVOLVEMENT DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUAL COOLER/HEATER COOLING & HEATING SYSTEM DWC TERUMO CARDIOVASCULAR SYSTEMS CORP. 11160

    Patients

    Seq Age Sex Outcome Treatment
    1