BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUAL COOLER/HEATER

    MDR report key: 3063425 · Received April 12, 2013

    Report

    Report Number
    1828100-2013-00394
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 20, 2013
    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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT IS RELATED TO MEDWATCH 1828100-2013-00348. THE EVENT WAS REPORTED TO THE FIELD SERVICE REP (FSR) WHEN HE WAS AT THE USER FACILITY TO PERFORM PREVENTATIVE MAINTENANCE. THE FSR WAS UNABLE TO DUPLICATE THE EVENT AND WAS ABLE TO PURGE THE AIR OUT OF THE SYSTEM. THE FSR PERFORMED A PREVENTATIVE MAINTENANCE AND THE UNIT OPERATED TO MFR'S SPECIFICATIONS AND WAS RETURNED TO CLINICAL USE. IF ADD'L INFO BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE OPERATING ROOM STAFF WAS UNABLE TO PURGE AIR FROM THE UNIT. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO DELAYS, NO BLOOD LOSS OR NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158099 DUAL COOLER/HEATER COOLING & HEATING SYSTEM DWC TERUMO CARDIOVASCULAR SYSTEMS CORP. 11160

    Patients

    Seq Age Sex Outcome Treatment
    1