BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRIMAG MOTOR, US

    MDR report key: 19824202 · Received July 25, 2024

    Report

    Report Number
    2916596-2024-04828
    Event Type
    Malfunction
    Date Received
    July 25, 2024
    Date of Event
    July 12, 2024
    Report Date
    October 28, 2024
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    QNR
    UDI-DI
    07640135140078
    PMA / PMN Number
    K020271
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    SECTION D4: PRIMARY UDI CORRECTED SECTION G8: THE INITIAL REPORT WAS INCORRECTLY SUBMITTED WITH A CFN-BASED MANUFACTURER REPORT (MFR) NUMBER: 2916596-2024-04828. THE MFR NUMBER SHOULD HAVE BEEN FEI-BASED WITH THE 10-DIGIT FEI BEING 3003306248. SECTIONS H5 AND H8: CORRECTED FOR REUSABLE MEDICAL DEVICE MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENTS OF THE CENTRIMAG MOTOR FEELING WARMER THAN EXPECTED, AND A HIGHER LEVEL OF NOISE FROM THE PUMP WHILE THE MOTOR WAS IN USE, WERE NOT CONFIRMED. THE RETURNED CENTRIMAG MOTOR (SERIAL NUMBER (B)(6) WAS FUNCTIONALLY TESTED AT THE SERVICE DEPOT FOR AN EXTENDED PERIOD AND PERFORMED AS INTENDED THROUGHOUT ALL TESTING. ATYPICAL EVENTS WERE UNABLE TO BE REPRODUCED, EVEN WHEN THE MOTOR¿S CABLE WAS MANIPULATED. A LOG FILE WAS EXTRACTED FROM THE RETURNED CONSOLE, AND NO ATYPICAL EVENTS OR ALARMS WERE CAPTURED; THE SYSTEM OPERATED AROUND THE SET SPEED AS INTENDED THROUGHOUT THE DATA. AVAILABLE INFORMATION INDICATES THAT THE EVENTS RESOLVED UPON EXCHANGING THE CENTRIMAG MOTOR. THE ROOT CAUSES OF THE REPORTED EVENTS WERE UNABLE TO BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD FOR CENTRIMAG MOTOR, SERIAL NUMBER (B)(6), SHOWED THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. THE 2ND GENERATION CENTRIMAG SYSTEM OPERATING MANUAL (REV. M) PROVIDES INFORMATION REGARDING EMERGENCY/TROUBLESHOOTING IN SECTION 10. THE RECOMMENDED PRACTICE WHENEVER THERE IS A CONSOLE OR MOTOR MALFUNCTION IS TO REPLACE THE CONSOLE AND MOTOR AS A SET. REMOVE THE BLOOD PUMP FROM THE MALFUNCTIONING MOTOR AND CONSOLE AND PLACE THE BLOOD PUMP IN THE BACK-UP MOTOR AND CONSOLE. SWITCH ALL COMPONENTS (CONSOLE, MOTOR, FLOW PROBE AND CABLES) SIMULTANEOUSLY TO CONTINUE PATIENT SUPPORT, AND THEN PERFORM TROUBLESHOOTING ON THE NON-FUNCTIONING SYSTEM, WHEN IT IS NO LONGER BEING USED FOR PATIENT SUPPORT. THE CENTRIMAG MOTOR IFU (REV. 06), IN SECTION TITLED "WARNINGS," INDICATES THAT THE MOTOR MAY FEEL WARM TO THE TOUCH. OVERHEATING IS CONFIRMED BY A MOTOR OVER TEMP CONSOLE ALERT MESSAGE AND TEMPERATURE SUFFICIENT TO PREVENT THE USER FROM PLACING AND HOLDING A HAND ON THE MOTOR HOUSING. CLAMP THE RETURN TUBING AND SWITCH TO THE BACKUP SYSTEM. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WITHIN 8 HOURS OF CANNULATION, MEDICAL STAFF NOTED THE MOTOR WAS PARTICULARLY HOT EVEN FOR SETTING OF RUNNING AT HIGH RPMS. THERE WAS NO EXCESSIVE CHUGGING OR CHATTER. THE PUMP APPEARED TO HAVE BEEN SEATED CORRECTLY, BIT WAS NOTED TO HAVE BEEN LOUDER THAN THOUGHT NORMAL. IT WAS AT 5000 RPM AND FLOW WAS AT 3.9 LPM. THE ISSUE RESOLVED AFTER THE MOTOR WAS EXCHANGED; IT WAS NOTED THAT THE CONSOLE WAS EXCHANGED CONCURRENT WITH THE MOTOR EXCHANGE. THE BLOOD PUMP WAS NOT EXCHANGED, AND THE NOISE LEVEL WAS DEEMED MORE ACCEPTABLE AND NORMAL AFTER THE MOTOR WAS EXCHANGED; THERE WAS NO CONCERN WITH THE PARTICULATE MATTER IN THE BLOOD PUMP. THE PATIENT STATUS WAS STABLE AND UNCHANGED. THERE WERE NO ADVERSE EVENTS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2371040 CENTRIMAG MOTOR, US BLOOD PUMP FOR ECMO, LONG-TERM (> 6 HOURS) USE QNR THORATEC SWITZERLAND GMBH 102956 7348960 07640135140078

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female