BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO TCM II COOLING AND HEATING SYSTEM

    MDR report key: 3063298 · Received April 11, 2013

    Report

    Report Number
    1828100-2013-00349
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 22, 2013
    Report Date
    March 22, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE REP (FSR) LOOKED AT THE UNIT ON (B)(6) 2013 AND COULD NOT DUPLICATE THE PROBLEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE CARDIOPLEGIA WOULD NOT GET COLD ENOUGH ON THE COOLER HEATER UNIT. THE DEVICE WAS NOT CHANGED OUT, AS THE PERFUSIONIST (CCP)ADDED ICE TO RESOLVE THE ISSUE. THERE WAS A COUPLE MINUTE DELAY TO COOL THE CARDIOPLEGIA. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO DELAYS, NO BLOOD LOSS OR NO ADVERSE CONSEQUENCES TO THE PATIENT. PER THE CLINICAL REVIEW: ACCORDING TO THE CCP, SHE WAS NOT ABLE TO DELIVER COLD BLOOD CARDIOPLEGIA SOLUTION AT A TEMPERATURE BELOW TWELVE DEGREES CELSIUS. IN ORDER TO ENHANCE THE COOLING CAPACITY, THE CCP ADDED ICE CUBES TO THE LARGE TANK OF THE UNIT. THIS DROPPED THE WATER TEMP OF THE LARGE TANK AND ALSO RESULTED IN A REDUCTION OF THE TEMP OF THE CARDIOPLEGIA SOLUTION TEMPERATURE. GATHERING AND ADDING ICE TO THE LARGE TANK INCREASED THE DELIVERY TIME OF THE CARDIOPLEGIA SOLUTION BY TWO MINUTES. THIS DELAY HAD NO IMPACT ON THE ABILITY TO QUICKLY ARREST THE HEART AND THERE WERE NO INDICATIONS OF INADEQUATE MYOCARDIAL PROTECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155387 TERUMO TCM II COOLING AND HEATING SYSTEM DWC TERUMO CARDIOVASCULAR SYSTEMS CORP. 4415

    Patients

    Seq Age Sex Outcome Treatment
    1