BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 3042339 · Received April 4, 2013

    Report

    Report Number
    1828100-2013-00327
    Event Type
    Malfunction
    Date Received
    April 4, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 15, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT WAS CONFIRMED BY THE FIELD SERVICE REPRESENTATIVE (FSR) VIA VIDEO PROVIDED BY THE CUSTOMER. THE FSR REPLACED THE SMALL DISPLAY ASSEMBLY. WITH THE COMPONENT REPLACED, THE UNIT OPERATED TO MANUFACTURER SPECIFICATIONS AND THE UNIT WAS RETURNED TO CLINICAL USE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. THIS COMPLAINT IS RELATED TO MDR #1828100-2013-00326.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, AFTER TWO HOUSE OF USE, THE ROLLER PUMP HAD A "FLASHING DISPLAY", HOWEVER THEY COULD CONTINUE TO CONTROL THE PUMP FROM THE CENTRAL CONTROL MONITOR (CCM) TOUCHSCREEN. THERE WERE NO ERROR MESSAGES OR AUDIBLE TONE, THE DISPLAY ONLY FLASHED. AT FIRST, THE NUMERICS WERE VISIBLE DURING ON FLASH STATE. THEN LATER, THE ON FLASH CYCLE WAS ONLY GRAY STATIC THE DEVICE WAS NOT CHANGED OUT. 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
    138522 TERUMO ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEM CORP 816571

    Patients

    Seq Age Sex Outcome Treatment
    1