BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 3231116 · Received July 12, 2013

    Report

    Report Number
    1828100-2013-00658
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 20, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS CONFIRMED BY THE FIELD SERVICE REPRESENTATIVE (FSR). THE FSR CHECKED THE BATTERY CAPACITY WHICH READ 17.5 AH BUT THE SYSTEM WOULD NOT BOOT-UP ON BATTERY POWER. TECHNICAL SUPPORT WAS CONTACTED REGARDING THE BATTERY CAPACITY. TECHNICAL SUPPORT SUGGESTED THE FSR REPLACE THE CIRCUIT BREAKER. THE FSR REPLACED THE CIRCUIT BREAKER BUT THE SAME ISSUE OCCURRED. THE FSR REPLACED THE POWER MANAGER BOARD AND BATTERIES, WHICH ALLOWED THE SYSTEM TO FULLY CHARGE. WITH THE BATTERIES AND POWER MANAGER BOARD REPLACED, THE SYSTEM OPERATED TO MANUFACTURER SPECIFICATIONS AND WAS RETURNED TO CLINICAL USE. THE SUSPECT COMPONENTS WERE RETURNED TO THE MANUFACTURER FOR FURTHER EVALUATION. 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, WHEN THE PERFUSION SYSTEM WAS UNPLUGGED, IT SHUT DOWN. THE USER WAS MOVING THE SYSTEM INTO THE OPERATING ROOM (OR) FOR SURGERY WHEN THIS OCCURRED. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. 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
    324643 TERUMO ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 801763

    Patients

    Seq Age Sex Outcome Treatment
    1