BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 2102660 · Received May 23, 2011

    Report

    Report Number
    1828100-2011-01465
    Event Type
    Malfunction
    Date Received
    May 23, 2011
    Date of Event
    April 28, 2011
    Report Date
    May 23, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP
    Product Code
    DTQ
    PMA / PMN Number
    K915183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    DURING PRIMING OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THAT HE COULD NOT GET THE LEVEL ALERT OR ALARM SENSORS TO NOT ALARM WHEN PROPERLY MOUNTED ON A PRIMED RESERVOIR WITHOUT USING AN EXCESSIVE AMOUNT OF GEL. AN ALTERNATE DEVICE WAS EMPLOYED FOR THE PROCEDURE. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PT AS A RESULT OF THIS EVENT. IT WAS CONFIRMED BY THE FIELD SERVICE REPRESENTATIVE THAT THE SENSORS WERE NOT EVEN TOUCHING THE BLOCK, SO THEY ALWAYS GENERATED ALARMS. A NEW LEVEL ALERT SENSOR WAS INSTALLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO PERFUSION SYSTEM 8000 HEART LUNG CONSOLE LEVEL SENSOR DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP 195215

    Patients

    Seq Age Sex Outcome Treatment
    1