BEUDAMED
    FDA Adverse Event Injury Summary report: N

    540T EXTERNAL DRIVE MOTOR

    MDR report key: 6052201 · Received October 24, 2016

    Report

    Report Number
    2184009-2016-00019
    Event Type
    Injury
    Date Received
    October 24, 2016
    Date of Event
    October 5, 2016
    Report Date
    December 1, 2017
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    DWA
    PMA / PMN Number
    K051303
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT WAS CONFIRMED FOR THE REPORTED FLOW INCREASE. THE 540T EXTERNAL DRIVE MOTOR WAS OUT OF SPECIFICATION AND WOULD NOT SPIN. THE ISSUE WAS RESOLVED BY REPLACING THE MOTOR, LOWER HOUSING UNIT, AND MAGNET WINDOW. THE DEVICE WAS CLEANED AND THE MAGNET CALIBRATED. IT IS UNKNOWN WHAT MAY HAVE CAUSED THIS OCCURRENCE. POST-REPAIR TESTING WAS PERFORMED PER SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORD FOUND NO ABNORMALITIES DURING MANUFACTURING THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE PATIENT EXPIRED POST-SURGERY DUE TO BLEEDING. IT WAS CONFIRMED THAT PATIENT¿S DEATH WAS UNRELATED TO THE EXTERNAL DRIVE MOTOR. THERE ARE NO CURRENT TRENDS.

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE PRODUCT HAS NOT BEEN RETURNED FOR ANALYSIS AND NO DEFINITIVE CONCLUSIONS CAN BE MADE REGARDING THE ROOT CAUSE OF THE CLINICAL OBSERVATION. MEDTRONIC'S INVESTIGATION IS IN PROCESS. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REPORTING THAT DURING USE OF THIS 540T EXTERNAL DRIVE MOTOR, USED ON A 550 BIO-CONSOLE INSTRUMENT, THE UNIT EXPERIENCED AN INCREASE IN FLOW AFTER FOUR HOURS OF REGULAR PERFORMANCE. THE USER NOTICED A FLOW INCREASE (1 L/MIN, CEREBRAL PRESSURE: 77MMHG TO 5 L/MIN, CEREBRAL PRESSURE: 220 MMHG) AND THE MOTOR HAD A HIGH ACOUSTIC NOISE. THE USER STOPPED THE PUMP WITH THE RPM (REVOLUTIONS PER MINUTE) POTENTIOMETER CONTROLLER AND POWERED OFF THE 550 BIO-CONSOLE. WHEN THE INSTRUMENT WAS POWERED BACK ON THE RPM DISPLAYED WAS 500 RPM, BUT THE EFFECTIVE SPEED WAS HIGH AND THE FLOW/CEREBRAL PRESSURE WERE ALSO HIGH. A HAND CRANK WAS USED FOR THIRTY SECONDS WHILE THE EXTERNAL DRIVER MOTOR WAS CHANGED WITH A BACKUP (SERIAL NUMBER (B)(4)). THE PERFUSION CASE WAS SUCCESSFULLY COMPLETED. THE PATIENT EXPIRED POST-SURGERY DUE TO BLEEDING. IT WAS CONFIRMED THAT PATIENT¿S DEATH WAS UNRELATED TO THE EXTERNAL DRIVE MOTOR. THE PRODUCT WAS RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REPORTING THAT DURING USE OF THIS 540T EXTERNAL DRIVER MOTOR, USED ON A 550 BIO-CONSOLE INSTRUMENT, THE UNIT EXPERIENCED AN INCREASE IN FLOW AFTER FOUR HOURS OF REGULAR PERFORMANCE. THE USER NOTICED A FLOW INCREASE (1 L/MIN, CEREBRAL PRESSURE: 77MMHG TO 5 L/MIN, CEREBRAL PRESSURE: 220 MMHG) AND THE MOTOR HAD A HIGH ACOUSTIC NOISE. THE USER STOPPED THE PUMP WITH THE RPM (REVOLUTIONS PER MINUTE) POTENTIOMETER CONTROLLER AND POWERED OFF THE 550 BIO-CONSOLE. WHEN THE INSTRUMENT WAS POWERED BACK ON THE RPM DISPLAYED WAS 500 RPM, BUT THE EFFECTIVE SPEED WAS HIGH AND THE FLOW/CEREBRAL PRESSURE WERE ALSO HIGH. A HAND CRANK WAS USED FOR THIRTY SECONDS WHILE THE EXTERNAL DRIVER MOTOR WAS CHANGED WITH A BACKUP (SERIAL NUMBER (B)()). THE PERFUSION CASE WAS SUCCESSFULLY COMPLETED. THE PATIENT EXPIRED POST-SURGERY DUE TO BLEEDING. IT WAS CONFIRMED THAT PATIENT'S DEATH WAS UNRELATED TO THE EXTERNAL DRIVE MOTOR. IT WAS STATED THAT THE EXTERNAL DRIVER MOTOR WILL BE RETURNED FOR ANALYSIS, BUT HAS NOT YET BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703980 540T EXTERNAL DRIVE MOTOR CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS DWA PERFUSION SYSTEMS FA95120-003

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention