BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 1512484 · Received October 15, 2009

    Report

    Report Number
    1828100-2009-00511
    Event Type
    Malfunction
    Date Received
    October 15, 2009
    Date of Event
    September 17, 2009
    Report Date
    October 15, 2009
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    KRL
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    DURING PREPARATION FOR USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED, THE AIR BUBBLE DETECTOR WOULD NOT RESET. THE DEVICE WAS USED FOR THE PROCEDURE. THE USER REPORTED, THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WAS NO ADVERSE CONSEQUENCE 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 AIR BUBBLE DETECTOR KRL TERUMO CARDIOVASCULAR SYSTEMS CORP. 5773

    Patients

    Seq Age Sex Outcome Treatment
    1