BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 1061605 · Received June 17, 2008

    Report

    Report Number
    1828100-2008-00302
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    May 27, 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
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL IN PROGRESS BUT NOT CONCLUDED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO ADVANCED PERFUSION SYSTEM 1 AIR BUBBLE DETECTOR KRL TERUMO CARDIOVASCULAR SYSTEMS CORP. 5791

    Patients

    Seq Age Sex Outcome Treatment
    1