BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 3102623 · Received May 1, 2013

    Report

    Report Number
    1828100-2013-00398
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Date of Event
    February 1, 2013
    Report Date
    April 9, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K915183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DOES NOT WANT THIS MONITOR FIXED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE TEMP SECTION OF THE ARTERIAL MONITOR DID NOT LIGHT UP. THE DEVICE WAS NOT CHARGED OUT, AS THEY USED THE CARDIOPLEGIA MONITOR TO KEEP TRACK OF THE TEMP. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO DELAYS, NO BLOOD LOSS OR NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190676 TERUMO PERFUSION SYSTEM 8000 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 16413

    Patients

    Seq Age Sex Outcome Treatment
    1