BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 3669922 · Received November 20, 2013

    Report

    Report Number
    1828100-2013-01041
    Event Type
    Malfunction
    Date Received
    November 20, 2013
    Date of Event
    October 25, 2013
    Report Date
    October 30, 2013
    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 ON (B)(4) 2013. THIS COMPLAINT IS RELATED TO MFR #182810-2013-01032. THE CARDIOPLEGIA PRESSURE MODULE DID GET TWO PRESSURE ALERTS AND ALARMS AT 3:10:47 PM, AFTER THE SYSTEM WAS REBOOTED AND A PERFUSION SCREEN WAS OPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE PERFUSION SYSTEM WAS POWERED AND AFTER IT WAS ON PERFUSION DISPLAY, IT INDICATED "CHECK THE FLOW SENSOR" AND ALARMED. IT USED TWO FLOW SENSORS AND TWO MODULES, AND ONE OF THEM INDICATED FLOW RATE [-]. THIS MODULE ALARMED AND INDICATED FLOW RATE [-] EVEN THOUGH WE EXCHANGED TO NORMALLY OPERATING SENSOR. WHEN THE PROBLEM OCCURRED, ONE OF TWO PRESSURE MODULES WAS LIT RED. THE DEVICE WAS NOT CHANGED OUT, AS THE USER CONTINUED TO USE THIS SYSTEM AFTER THEY REBOOTED THE SYSTEM. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO DELAYS, NO BLOOD LOSS OR NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603682 TERUMO ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 802112

    Patients

    Seq Age Sex Outcome Treatment
    1