BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTRIMAG 2ND GENERATION PRIMARY CONSOLE

    MDR report key: 8647138 · Received May 28, 2019

    Report

    Report Number
    2916596-2019-02514
    Event Type
    Injury
    Date Received
    May 28, 2019
    Date of Event
    May 23, 2019
    Report Date
    February 17, 2020
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    DWA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS B1, D4, E3, E4, H4: ADDITIONAL INFORMATION. SECTIONS D10, H1, H3: CORRECTION. MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF A HUMMING NOISE FROM THE MOTOR WAS NOT CONFIRMED; HOWEVER, THE REPORTED EVENT OF BLANK CONSOLE DISPLAY AND A DROP IN SPEED WAS CONFIRMED. THE CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WAS RETURNED FOR ANALYSIS. A LOG FILE WAS DOWNLOADED FROM THE CONSOLE. A REVIEW OF THE DOWNLOADED LOG FILE SHOWED EVENTS SPANNING APPROXIMATELY 12 DAYS ((B)(6) 2019 ¿ (B)(6) 2019 PER TIME STAMP). THE CONSOLE WAS OPERATING THE MOTOR AT A SPEED OF ~3700 RPM WITH A FLOW ~3.4 LPM. ON (B)(6) 2019 AT 06:46, THE SUB FAULT ¿SF_IFD_SHUTDOWN_DETECTED¿ ACTIVATED AND TRIGGERED THE ALARMS ¿SYSTEM ALERT: S3¿ AND ¿FLOW SIGNAL INTERRUPTED: F2¿. THE SPEED DROPPED TO ~3200 RPM. THE ¿MOTOR DISCONNECTED: M2¿ ALARM ACTIVATED IN THE SAME TIME STAMP AS WELL. THE MOTOR AND FLOW DROPPED TO 0 RPM AND 0 LPM RESPECTIVELY. THE ALARMS WERE ABLE TO BE MUTED AND CLEARED. THE CONSOLE WAS FORWARDED TO THE SERVICE DEPOT FOR ANALYSIS. THE RETURNED CONSOLE WAS EVALUATED AND TESTED. THE REPORTED EVENT WAS UNABLE TO BE REPRODUCED. THE CONSOLE WAS RUN FOR AN EXTENDED PERIOD OF TIME WITH A TEST MOTOR AND WITH THE RETURNED AND ASSOCIATED MOTOR AND FLOW PROBE. NO ALARMS OR ISSUES WITH THE FLOW OR THE SCREEN, OCCURRED AT ANY TIME. THE CONSOLE FUNCTIONED AS INTENDED. A SUCCESSFUL BATTERY MAINTENANCE WAS PERFORMED. PER FIELD ACTION ¿FA-Q318-MCS-1¿ (SEE MFR. REPORT NUMBER 2916596-2019-02513), IT WAS CONFIRMED THAT THE NEW BACKUP SYSTEM WARNING LABEL WAS PRESENT ON THE BACK OF THE CONSOLE. REPORTS OF SIMILAR EVENTS HAVE BEEN DOCUMENTED AND CORRECTIVE ACTION HAD BEEN INITIATED TO INVESTIGATE THE ISSUE FURTHER. THE INVESTIGATION HAS DETERMINED THAT THE ISSUE IS NOT RELATED TO A 2ND GENERATION PRIMARY CONSOLE RELATED ISSUE. REPORTS OF SIMILAR EVENTS WILL CONTINUE TO BE TRACKED AND MONITORED. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    APPROXIMATE AGE OF THE DEVICE IS 3 DAYS. THE PATIENT REMAINS ON CENTRIMAG SUPPORT WITH NO FURTHER ISSUES REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ON 3700 RPMS AND FLOW WAS 3.4 LPM AND STABLE. AT 12:45AM THE CENTRIMAG MOTOR STARTED TO MAKE A HUMMING NOISE AND CLINICIAN PLACED HER HAND ON THE MOTOR AND FELT A MUCH STRONGER VIBRATION THAN NORMAL. ALARM FLOW BELOW MINIMUM SOUNDED AND THEN THE LPM APPEARED TO BE DASHES. THE RPM DROPPED SUDDENLY FROM 3700 TO 3200 RPM. THE CONSOLE SCREEN BLANKED OUT EVEN THOUGH THE MONITOR STILL WAS ON SHOWING RPM AT 3200 AND DASHES ON LPM. CLINICIAN ATTEMPTED TO RAISED THE RPMS ON MONITOR WITH NO RESPONSE. THE NURSE CALLED OUT FOR ASSISTANCE AND THEN INITIATED AN EMERGENCY SYSTEM EXCHANGE TO THE BACKUP SYSTEM. THE TOTAL EXCHANGE TIME FROM INITIAL ALARM TO REINITIATING OF FLOW TO THE BACKUP SYSTEM TOOK 45 SECONDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438681 CENTRIMAG 2ND GENERATION PRIMARY CONSOLE CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS DWA THORATEC SWITZERLAND GMBH 201-30300

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR