BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTRIMAG MOTOR, OUS

    MDR report key: 23340177 · Received October 20, 2025

    Report

    Report Number
    3003306248-2025-00282
    Event Type
    Injury
    Date Received
    October 20, 2025
    Date of Event
    September 27, 2025
    Report Date
    January 14, 2026
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    QNR
    UDI-DI
    07640135140061
    PMA / PMN Number
    K020271
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D4: MANUFACTURE DATE (H4) WILL BE PROVIDED UPON INVESTIGATION. THE PRIMARY UDI NUMBER IN D4 IS REFLECTIVE OF ALL AVAILABLE INFORMATION. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENTS OF A PUMP STOP CAUTION MESSAGE BEING DISPLAYED ON THE CENTRIMAG SYSTEM, ALONGSIDE THE CENTRIMAG SYSTEM STOPPING, WERE CONFIRMED VIA THE LOG FILE. THE LOG FILE CAPTURED THE SYSTEM OPERATING AROUND THE SET SPEED ON (B)(6) 2025. ON THIS DATE, A PUMP STOP CAUTION MESSAGE WAS OBSERVED WHICH APPEARED TO BE CONSISTENT WITH THE PUMP STOP BUTTON BEING PRESSED. THE PUMP WAS OBSERVED TO HAVE STOPPED APPROXIMATELY 5 SECONDS LATER, FOLLOWED BY THE PUMP STOP CAUTION MESSAGE DISAPPEARING AND A ¿PUMP STOPPED DUE TO USER REQUEST¿ FLAG. THESE EVENTS APPEARED CONSISTENT WITH THE PUMP STOP BUTTON BEING HELD FOR 5 SECONDS WHICH WOULD STOP THE PUMP. THE PATIENT¿S SET SPEED WAS RAMPED BACK UP A FEW SECONDS AFTER THE PUMP HAD STOPPED. SEVERAL MORE PUMP STOP CAUTION MESSAGES WERE INTERMITTENTLY OBSERVED THROUGHOUT THE REMAINDER OF THE DATA WHICH DID NOT LAST LONG ENOUGH TO CAUSE THE PUMP TO STOP, 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 FOR EXTENDED PERIODS AT THE EUROPEAN DISTRIBUTION CENTER. THE MOTOR WAS FOUND TO PERFORM 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. AVAILABLE INFORMATION FOR THIS EVENT INDICATES THAT THE SYSTEM¿S PUMP STOP BUTTON HADN¿T BEEN PRESSED, AND THE ROOT CAUSES OF THE REPORTED EVENTS WERE UNABLE TO BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. ADDITIONALLY, IT WAS FOUND DURING INVESTIGATION THAT THE CONNECTOR CAP WAS DAMAGED. 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 PROVIDES INFORMATION REGARDING EMERGENCY/TROUBLESHOOTING IN SECTION 9. 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 2ND GENERATION CENTRIMAG SYSTEM OPERATING MANUAL SECTION 5.7.3 ¿SYMBOLS ON THE CONSOLE, MONITOR, AND FLOW PROBES¿ INSTRUCTS USERS HOW TO STOP THE PUMP USING THE EMERGENCY PUMP STOP BUTTON. AN AUDIO ALARM WILL SOUND WHILE THE KEYPAD IS DEPRESSED, INDICATING THAT THE PUMP WILL BE STOPPED SOON. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 20 MINUTES AFTER BEING PUT ONTO THE CENTRIMAG UNIT, THE EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SOUNDED AN ALARM AS IF THE RED STOP BUTTON HAD BEEN PRESSED (IT HADN'T). THE RPM WAS READING ZERO AND HAD NO FLOW. THE PATIENT ARRESTED. THE RPM WAS RESTORED TO 4000 BY THE TIME TO ON-CALL TEAM ARRIVED. THE ECMO CIRCUIT WAS CHANGED TO THE BACKUP CENTRIMAG MOTOR AND CONSOLE.

    Description of Event or Problem · 0

    IT WAS BELIEVED THAT IT WAS A PROBABLE CONSOLE OR MOTOR ISSUE WHICH RESULTED IN THIS EVENT. THE MONITOR WAS NOT CHANGED ON THE DAY OF THE EVENT. THE PATIENT ULTIMATELY RECEIVED A HEART TRANSPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827187 CENTRIMAG MOTOR, OUS BLOOD PUMP FOR ECMO, LONG-TERM (> 6 HOURS) USE QNR THORATEC SWITZERLAND GMBH 201-10002 7375825 07640135140061

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Other