BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 2922003 · Received January 15, 2013

    Report

    Report Number
    1828100-2013-00024
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 21, 2012
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS 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

    SOFTWARE DATA LOGS WERE RETURNED TO THE MANUFACTURER FOR FURTHER EVALUATION. THIS EVENT INVOLVED ALL FOUR ROLLER PUMP ON ONE SYSTEM, SEE THE FOLLOWING MDRS ALSO: 1828100-2013-00021, 1828100-2013-00022 AND 1828100-2013-00023. EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, AN "COVER-OPEN" ALARM OCCURRED ON THE MAIN PUMP AND VENT PUMP, AND WAS DISPLAYED ON CENTRAL CONTROL MONITOR (CCM). THE ALARM SOUNDED WITHOUT CAUSE, AS BOTH PUMPS' COVERS WERE CLOSED. AFTERWARDS, THERE WAS NO ERROR MESSAGE ON THE CCM AND THE ALARM CONTINUED TO SOUND. AFTER THE USER ESCAPED FROM PERFUSION SCREEN OF THE CCM, THEY ENTERED THE PERFUSION SCREEN AGAIN, BUT THE ALARM WAS NOT CANCELED. AFTER A REBOOT, THE ERROR WAS CANCELLED. THE DEVICE WAS NOT CHANGED OUT, AS THEY CONTINUED TO USE IT FOR THE OPERATION AND THERE WERE NO ERRORS DURING THE OPERATION. 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
    22554 TERUMO ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 801040

    Patients

    Seq Age Sex Outcome Treatment
    1