BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 1061606 · Received June 17, 2008

    Report

    Report Number
    1828100-2008-00326
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    May 23, 2008
    Report Date
    June 17, 2008
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    KRL
    PMA / PMN Number
    K940651
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL IN PROGRESS, BUT NOT CONCLUDED.

    Description of Event or Problem · 1

    DURING USE FOR CARDIOPULMONARY BYPASS SURGERY, THE AIR BUBBLE DETECTION SYSTEM REPEATEDLY ALARMED EVEN THOUGH AIR WAS NOT PRESENT. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO PERFUSION SYSTEM 8000 AIR BUBBLE DETECTOR KRL TERUMO CARDIOVASCULAR SYSTEMS CORP. 5773

    Patients

    Seq Age Sex Outcome Treatment
    1