BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 2210307 · Received August 8, 2011

    Report

    Report Number
    1828100-2011-02363
    Event Type
    Malfunction
    Date Received
    August 8, 2011
    Date of Event
    July 15, 2011
    Report Date
    August 8, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING PREVENTATIVE MAINTENANCE OF THE DEVICE, THE FIELD SERVICE REP REPORTED THAT THERE WAS A CREASE IN THE MEMBRANE OF THE ROLLER HEAD. FURTHER INVESTIGATION FOUND A CUT AT THE LOWER END OF THE CREASE. A NEW MEMBRANE WAS INSTALLED. SINCE THE EVENT OCCURRED DURING PREVENTATIVE MAINTENANCE, THERE WAS NO PT INVOLVEMENT DURING THE 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 801041

    Patients

    Seq Age Sex Outcome Treatment
    1