BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUAL COOLER/HEATER

    MDR report key: 2100542 · Received May 13, 2011

    Report

    Report Number
    1828100-2011-01489
    Event Type
    Malfunction
    Date Received
    May 13, 2011
    Date of Event
    April 19, 2011
    Report Date
    May 13, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTR
    PMA / PMN Number
    PREAMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THAT THE UNIT LEAKED. THE UNIT WAS NOT CHANGED OUT. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUAL COOLER/HEATER WATER SUPPLY BRACKET DTR TERUMO CARDIOVASCULAR SYSTEMS CORP. 4979

    Patients

    Seq Age Sex Outcome Treatment
    1