BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 1221487 · Received November 5, 2008

    Report

    Report Number
    1828100-2008-00538
    Event Type
    Malfunction
    Date Received
    November 5, 2008
    Date of Event
    October 13, 2008
    Report Date
    November 5, 2008
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K915183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    DURING SET-UP FOR A CARDIOPULMONARY BYPASS PROCEDURE, IT WAS REPORTED THAT THE LEFT HAND TIMER ON THE ARTERIAL MONITOR WOULD NOT WORK. IT WAS ALSO REPORTED THAT WHEN SETTING THE PRESSURE ALARMS ON THE ARTERIAL MONITOR, THE SYSTEM WOULD GO IN THE UP DIRECTION, BUT NOT DOWN. 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 TERUMO PERFUSION SYSTEM 8000 ROLLER PUMP DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 16413

    Patients

    Seq Age Sex Outcome Treatment
    1