BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 1841876 · Received September 20, 2010

    Report

    Report Number
    1828100-2010-01495
    Event Type
    Malfunction
    Date Received
    September 20, 2010
    Date of Event
    August 26, 2010
    Report Date
    September 20, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    DURING NON CLINICAL ACTIVITY, THE USER OBSERVED A SEPARATION BETWEEN THE LAMP PLUG AND THE CABLE. THE USER REPORTED THE LAMP PLUG WAS DEFORMED. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. SINCE THE EVENT OCCURRED DURING NON CLINICAL ACTIVITY, THERE WAS NO PATIENT INVOLVEMENT DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO ADVANCED PERFUSION SYSTEM 1 HEART LUNG CONSOLE (LAMP) DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 801558

    Patients

    Seq Age Sex Outcome Treatment
    1