BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 2802555 · Received October 19, 2012

    Report

    Report Number
    1828100-2012-01358
    Event Type
    Malfunction
    Date Received
    October 19, 2012
    Date of Event
    September 24, 2012
    Report Date
    September 24, 2012
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROCESS, BUT NOT YET COMPLETED. THE FIELD SERVICE REPRESENTATIVE (FSR) WAS ABLE TO CORRECT THE ISSUE OVER THE TELEPHONE WITH THE USER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE UNIT DISPLAYED AN ERROR FOR THE VENOUS TEMPERATURE. THE USER WAS GETTING A BAR ACROSS THE TOP OF THE SCREEN AND ALSO "?" ON THE MODULES. THE DEVICE WAS NOT CHANGED OUT. PER THE FIELD SERVICE REPRESENTATIVE (FSR), THE MODULE WAS RESEATED AND THE USER FINISHED CASE WITHOUT ISSUE. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO DELAYS, NO BLOOD LOSS OR NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 802114

    Patients

    Seq Age Sex Outcome Treatment
    1