BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 2833460 · Received October 26, 2012

    Report

    Report Number
    1828100-2012-01372
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    October 2, 2012
    Report Date
    October 2, 2012
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE REPRESENTATIVE (FSR) WAS UNABLE TO VERIFY THE EVENT. AS A PRECAUTION, THE FSR REPLACED THE POWER MANAGER BOARD AND SENT THE DATA LOGS TO THE MANUFACTURER FOR FURTHER EVALUATION. THE DATA LOG REVIEW DETERMINED THERE WAS A LOOSE OR FAILED RIBBON CABLE THAT GOES TO THE SINGLE BOARD COMPUTER (SBC) BOARD IN THE CENTRAL CONTROL MONITOR. THE FSR WAS UNABLE TO DUPLICATE THE REPORTED ISSUE AND REPLACED THE RIBBON CABLE AND THE SBC BOARD. THE UNIT WAS TESTED TO MANUFACTURER'S SPECIFICATIONS AND 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE CENTRAL CONTROL MONITOR DISPLAYED A MESSAGE "SYSTEM COMPUTER NEEDS SERVICE" AND THEN THE SCREEN LOCKED UP. THE CUSTOMER POWERED DOWN AND BACK UP, THE DEVICE FUNCTIONED AND WAS NOT CHANGED OUT. 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
    1 TERUMO ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEM CORP 801763

    Patients

    Seq Age Sex Outcome Treatment
    1