BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 3102578 · Received May 1, 2013

    Report

    Report Number
    1828100-2013-00414
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 8, 2013
    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

    EVAL IS IN PROGRESS, BUT NOT YET CONCLUDED. PER THE SVC REPAIR TECH (SRT) INITIAL EVAL, LINE NUMBER TWO FAILED. THE VOLTAGE READING WAS OUT OF SPECIFICATION, ON THE HIGH SIDE. HIGH LIMIT IS 2.551 VOLTS AND THE SENSOR WAS READING 3.57V. THE O2 SENSOR WAS EIGHTEEN MONTHS OLD AND THE SHELF LIFE IS ONLY SIX MONTHS.

    Description of Event or Problem · 1

    THE SVC REPAIR TECH (SRT) REPORTED THAT DURING ROUTINE TESTING OF THE DEVICE AT THE SVC CTR, THERE WAS AN OXYGEN (O2) SENSOR ERROR ON THE SYS. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190369 TERUMO ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 801188

    Patients

    Seq Age Sex Outcome Treatment
    1