BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTRIMAG MOTOR, US

    MDR report key: 23547833 · Received November 13, 2025

    Report

    Report Number
    3003306248-2025-00319
    Event Type
    Injury
    Date Received
    November 13, 2025
    Date of Event
    October 13, 2025
    Report Date
    February 18, 2026
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    QNR
    UDI-DI
    07640135140078
    PMA / PMN Number
    K020271
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF ATYPICAL FLOW VALUES OCCURRING ON THE CENTRIMAG SYSTEM WAS CONFIRMED VIA THE LOG FILE. THE LOG FILE CAPTURED SEVERAL INTERMITTENT F2: FLOW SIGNAL INTERRUPTED AND F3: FLOW BELOW MINIMUM ALARMS ON 13OCT2025 WHILE THE SYSTEM WAS IN USE. THESE ALARMS APPEARED TO HAVE BEEN CAUSED BY THE FLOW VALUES FLUCTUATING BELOW THE ALARM THRESHOLDS. THE ALARMS DID NOT PREVENT THE SYSTEM FROM OPERATING AT THE SET SPEED THROUGHOUT THE DATA, AND THE SYSTEM WAS OBSERVED TO HAVE BEEN MANUALLY SHUT DOWN AT THE END OF THE DATA TO PERFORM THE REPORTED EQUIPMENT EXCHANGE. THE RETURNED CENTRIMAG MOTOR (SERIAL NUMBER (B)(6)) WAS FUNCTIONALLY TESTED AT THE SERVICE DEPOT ALONGSIDE THE RETURNED CONSOLE AND FLOW PROBE (EACH EVALUATED SEPARATELY). THE RETURNED EQUIPMENT WAS FOUND TO FUNCTION AS INTENDED, AND ATYPICAL EVENTS WERE UNABLE TO BE REPRODUCED THROUGHOUT ALL TESTING. THE SERVICED AND TESTED MOTOR WAS RETURNED TO THE CUSTOMER SITE AFTER PASSING ALL TESTS PER PROCEDURE. QUESTIONS REGARDING THE EVENT WERE ASKED MULTIPLE TIMES AND NO RESPONSES WERE RECEIVED. THE ROOT CAUSE OF THE REPORTED EVENT WAS UNABLE TO BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD FOR THE 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 SECTION 4 "WARNINGS AND PRECAUTIONS" WARNS "ONE ADDITIONAL 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, MOTOR AND FLOW PROBE ARE REQUIRED AS BACKUP SYSTEM IN THE IMMEDIATE VICINITY OF EACH PATIENT WHENEVER THE CENTRIMAG OR PEDIVAS BLOOD PUMP IS USED. THE BACKUP CONSOLE MUST BE CONNECTED TO THE BACKUP MOTOR AND TO THE BACKUP FLOW PROBE, HAVE A BATTERY CHARGE SUFFICIENT FOR AT LEAST ONE HOUR OF OPERATION, BE CONNECTED TO AC POWER (EXCEPT DURING TRANSPORT) AND BE IMMEDIATELY AVAILABLE SHOULD THE MAIN CONSOLE, MOTOR OR FLOW PROBE EXPERIENCE A MALFUNCTION." THE 2ND GENERATION CENTRIMAG SYSTEM OPERATING MANUAL SECTION 12.1-"APPENDIX I ¿ CONSOLE ALARMS AND ALERTS" CONTAINS A LIST OF CONSOLE ALARMS AND ALERTS, INCLUDING FLOW-RELATED ALARMS, AS WELL AS APPROPRIATE OPERATOR RESPONSE TO THESE EVENTS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    A4 - PATIENT WEIGHT WAS NOT PROVIDED BY CUSTOMER. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FLOW HAD TO BE SET "QUITE HIGH" IN ORDER TO GET IT TO FLOW AT ALL, THEN COME BACK DOWN A BIT. A FEW HOURS LATER IN CARDIOVASCULAR, FLOWS WERE LOST AGAIN AND HAD TO SWITCH TO ANOTHER CIRCUIT. THERE WAS SOME CLOTTING IN THE VENOUS CANNULA. IT WAS NOTED THERE WAS ALSO A CORRELATION BETWEEN HEMODYNAMICS AND THE EVENT. THE CENTRIMAG CIRCUIT WAS EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1923649 CENTRIMAG MOTOR, US BLOOD PUMP FOR ECMO, LONG-TERM (> 6 HOURS) USE QNR THORATEC SWITZERLAND GMBH 102956 07640135140078

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown