BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 2030390 · Received March 7, 2011

    Report

    Report Number
    1828100-2011-00565
    Event Type
    Malfunction
    Date Received
    March 7, 2011
    Date of Event
    February 8, 2011
    Report Date
    March 7, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    DURING ROUTINE TESTING OF THE DEVICE AT THE SERVICE CENTER, THE USER REPORTED THAT THERE WAS AN INTERMITTENT OPEN SHIELD CONNECTION AT THE PUMP END OF THE PUMP CABLE. SINCE THE EVENT OCCURRED DURING ROUTINE TESTING OF THE DEVICE, 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 CABLE DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 801587

    Patients

    Seq Age Sex Outcome Treatment
    1