BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 2100508 · Received May 13, 2011

    Report

    Report Number
    1828100-2011-01553
    Event Type
    Malfunction
    Date Received
    May 13, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 13, 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 SERVICE TECHNICIAN REPORTED THAT THE LEVEL ALERT SENSOR HAD A CUT ON THE OUTER SLEEVE. SINCE THE EVENT OCCURRED DURING ROUTINE TESTING, 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 LEVEL SENSOR DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 195215

    Patients

    Seq Age Sex Outcome Treatment
    1