BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTRIMAG MOTOR, OUS

    MDR report key: 9262462 · Received October 31, 2019

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    Report

    Report Number
    2916596-2019-05098
    Event Type
    Injury
    Date Received
    October 31, 2019
    Date of Event
    July 7, 2019
    Report Date
    February 18, 2020
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    KFM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT THE MOTOR BEING NOISY AND JUDDERING WAS NOT CONFIRMED. THE CENTRIMAG MOTOR (SERIAL #: (B)(6)) WAS RETURNED FOR ANALYSIS TO THE EDC BELGIUM. A LOG FILE WAS DOWNLOADED FROM THE RETURNED AND ASSOCIATED CONSOLE (SERIAL #: (B)(6)) FOR REVIEW. A REVIEW OF THE DOWNLOADED LOG FILE SHOWED EVENTS SPANNING APPROXIMATELY 117 DAYS (29MAY19 ¿ 23SEP19 PER TIME STAMP). ON 04JUL19 AT 14:19 THE SUB FAULT ¿SF_IFD_FLOW_BELOW_MIN¿ ACTIVATED AND TRIGGERED A ¿FLOW BELOW MINIMUM: F3¿ ALARM. AT THE SAME TIME, THE SUB FAULTS ¿SF_LMC_DRIVE_TORQUE_SATURATED¿ AND ¿SF_IFD_UNDERSPEED¿ AND ¿SF_LMC_LEVITATION¿ TRIGGERED ¿SET PUMP SPEED NOT REACHED: M5¿ AND ¿MOTOR ALARM: M4¿ ALARMS. AT 14:20, A ¿MOTOR STOPPED: M1¿ ALARM ACTIVATED. THE RETURNED MOTOR WAS EVALUATED AND TESTED. THE MOTOR WAS TESTED WITH THE RETURNED AND ASSOCIATED FLOW PROBE (SERIAL #: (B)(6)) AND CONSOLE (SERIAL #: (SERIAL #: (B)(6)). THE SYSTEM WAS RUN FOR 10 DAYS AND NO ANOMALIES WERE FOUND. PREVENTATIVE MAINTENANCE AND A SAFETY TEST WERE PERFORMED PER PROCEDURE. THE ROOT CAUSE FOR THE REPORTED EVENT WAS NOT CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE EVENT IS UNKNOWN. THUS, THE EVENT IS ALSO REPORTED UNDER CMAG MOTOR (S/N: (B)(4)) AND REPORTED UNDER MFR # 2916596-2019-05097. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CENTRIMAG (CMAG) MOTOR BECAME NOISY AND JUDDERED. THE FLOW DROPPED AND THERE WAS A DAMPED CIRCUIT. THE SPEED WOULDN'T INCREASE. THE CMAG CONSOLE WAS CHANGED TO BACKUP CMAG CONSOLE. LOW FLOW ALARM SOUNDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1053830 CENTRIMAG MOTOR, OUS PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM THORATEC SWITZERLAND GMBH 201-10002

    Patients

    Seq Age Sex Outcome Treatment
    1