BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 1002565 · Received February 8, 2008

    Report

    Report Number
    1828100-2008-00066
    Event Type
    Malfunction
    Date Received
    February 8, 2008
    Date of Event
    January 8, 2008
    Report Date
    February 8, 2008
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL IN PROGRESS BUT NOT CONCLUDED.

    Description of Event or Problem · 1

    DURING INSTALLATION OF THE ROLLER PUMP, THE PLACEMENT OF THE TUBING CLAMP ASSEMBLY WAS VERY DIFFICULT BECAUSE OF INTERFERENCE WITH THE MATING COMPONENT. THE PART WAS SUCCESSFULLY ADJUSTED AND ASSEMBLY WAS COMPLETED. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO ADVANCED PERFUSION SYSTEM 1 ROLLER PUMP DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 816571

    Patients

    Seq Age Sex Outcome Treatment
    1