BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 1758431 · Received June 23, 2010

    Report

    Report Number
    1828100-2010-00622
    Event Type
    Malfunction
    Date Received
    June 23, 2010
    Date of Event
    May 25, 2010
    Report Date
    June 23, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    JOR
    PMA / PMN Number
    K915183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IN PROGRESS BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THE ALARM LEVEL SENSOR WAS DISCONNECTED FROM THE BACK OF THE SAFETY MONITOR. THE USER REPORTED THE PINS GOT STUCK IN THE CONNECTOR. THE USER REPLACED THE LEVEL DETECTION CIRCUIT BOARD AND THE LEVEL SENSOR. 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 SAFETY MONITOR JOR TERUMO CARDIOVASCULAR SYSTEMS CORP. 16404

    Patients

    Seq Age Sex Outcome Treatment
    1