BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 3900134 · Received May 1, 2014

    Report

    Report Number
    1828100-2014-00347
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 8, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL INS IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    THE SUBSIDIARY SERVICE REPAIR TECHNICIAN (SRT) REPORTED THAT DURING ROUTINE TESTING OF THE DEVICE AT THE SUBSIDIARY'S MANUFACTURING ENGINEERING CENTER (MEC), THERE IS A GREATER DIFFERENCE BETWEEN MEASUREMENT VALUE AND ACTUAL VALUE. THIS IS A DEMO UNIT (CV GROUP) FOR SUBSIDIARY SITE. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263946 TERUMO ADVANCED PERFUSION SYSTEM 1 APS 1 (EPGS) DTQ TERUMO CARDIOVASCULAR SYSTEM CORP 801188

    Patients

    Seq Age Sex Outcome Treatment
    1