BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE (VAS/ECMO)

    MDR report key: 23076575 · Received September 17, 2025

    Report

    Report Number
    3003306248-2025-00263
    Event Type
    Malfunction
    Date Received
    September 17, 2025
    Date of Event
    September 3, 2025
    Report Date
    February 4, 2026
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    DWA
    UDI-DI
    07640135140689
    PMA / PMN Number
    K131179
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A. PATIENT INFORMATION NO PATIENT INVOLVEMENT, NOT IN USE WITH A PATIENT. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF THE CENTRIMAG CONSOLE¿S INTERNAL BATTERY NOT PASSING BATTERY MAINTENANCE WAS CONFIRMED VIA THE CONSOLE¿S FUNCTIONAL ANALYSIS AND THE DOWNLOADED LOG FILE. THE RETURNED CENTRIMAG CONSOLE (SERIAL NUMBER (B)(6)) WAS FUNCTIONALLY TESTED AT THE SERVICE DEPOT. A BATTERY MAINTENANCE TEST WAS PERFORMED, AND THE BATTERY DID NOT PASS. EVENTS RESOLVED WHEN A NEW INTERNAL BATTERY WAS PLACED WITHIN THE RETURNED CONSOLE, ISOLATING THE CAUSE OF THE ISSUE TO THE BATTERY. THE NEW BATTERY INSTALLED INTO THE RETURNED CONSOLE PASSED THE BATTERY MAINTENANCE TESTING. THE SERVICED AND TESTED CONSOLE WAS THEN RETURNED TO THE CUSTOMER SITE AFTER PASSING ALL TESTS PER PROCEDURE. THE EXTRACTED LOG FILE CAPTURED THE BATTERY MAINTENANCE ALARM ON 08JAN2026 WHILE THE CONSOLE WAS NOT IN PATIENT USE. THE INTERNAL BATTERY WAS DISPOSED OF BY THE SERVICE DEPOT AND NO FURTHER TESTING WAS PERFORMED. THE ROOT CAUSE OF THE REPORTED EVENT WAS ISOLATED TO AN ISSUE WITH THE CONSOLE¿S INTERNAL BATTERY; HOWEVER, THE ROOT CAUSE OF THE BATTERY¿S ISSUE WAS UNABLE TO BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE RECORDS REVEALED THAT THE CENTRIMAG 2ND GENERATION CONSOLE, SERIAL NUMBER (B)(6), WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. THE CURRENT REVISION OF THE INSTRUCTIONS FOR USE (IFU) CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. THE 2ND GENERATION CENTRIMAG SYSTEM OPERATING MANUAL SECTION 10 ¿ ¿EMERGENCIES/TROUBLESHOOTING¿ PROVIDES INSTRUCTIONS FOR OPERATION WHEN THERE IS A NEED TO EXCHANGE THE MAIN CONSOLE OR MOTOR WITH A BACKUP CONSOLE OR MOTOR. 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 8.3 ¿ ¿RECOMMENDED PREVENTIVE MAINTENANCE¿ INSTRUCTS USERS TO REGULARLY INSPECT THE CONSOLE FOR SIGNS OF DAMAGE AND TO RETURN THE CONSOLE BACK TO THORATEC FOR SERVICING IF ANY DAMAGE IS OBSERVED. THE 2ND GENERATION CENTRIMAG SYSTEM OPERATING MANUAL, SECTION 8.4 ¿ ¿BATTERY MAINTENANCE¿ INSTRUCTS USERS ON HOW TO PERFORM THE BATTERY MAINTENANCE PROCEDURE AND ON WHAT STEPS TO TAKE WHEN THE TEST DOES NOT PASS. THE 2ND GENERATION CENTRIMAG SYSTEM OPERATING MANUAL SECTION 12.1 ¿ "APPENDIX I ¿ PRIMARY CONSOLE ALARMS AND ALERTS" COVER ALL ALARMS (AUDITORY AND VISUAL), INCLUDING BATTERY RELATED ALARMS, AND THE APPROPRIATE ACTIONS TO TAKE IF THE ISSUE DOES NOT RESOLVE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CENTRIMAG BATTERY HAD A B4 ALARM AND REQUIRED MAINTENANCE. THE CENTRIMAG CONSOLE WAS CONNECTED TO POWER AND UPON POWERING IT ON IT DISPLAYED A ¿MAINTENANCE REQUIRED¿ ALERT. MAINTENANCE PROCEDURES WERE PERFORMED TWICE, BUT BOTH ATTEMPTS RESULTED IN ERROR MESSAGES. THE CONSOLE WAS NOT IN USE WITH A PATIENT. THE BATTERY WAS CURRENTLY VALID, WITH ITS NEXT SCHEDULED REPLACEMENT SET FOR (B)(6) 2026. THE BATTERY WILL BE REMOVED AND SENT FOR SCRAP. NO CONSEQUENCES WERE ASSOCIATED. NO LOG FILES WERE AVAILABLE. THE CONSOLE WOULD BE RETURNED FOR REPAIR. IT WAS NOTED THAT THE SAME BATTERY-RELATED FAILURE HAS OCCURRED FOR THREE CONSECUTIVE YEARS [PER-2023-0141408, PER-2024-0143145 AND PER-2024-0145530]. THEREFORE, IT WAS DECIDED TO REMOVE THE CONSOLE SN (B)(6) FROM THE CLIENT'S SITE AND SEND IT TO THE FACTORY FOR INSPECTION.

    Description of Event or Problem · 0

    PREVIOUS BATTERY-RELATED FAILURE EVENTS FOR THIS PRODUCT WERE REPORTED UNDER MFR #S: 3003306248-2023-05065 AND 3003306248-2024-04437.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1634652 CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE (VAS/ECMO) CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS DWA THORATEC SWITZERLAND GMBH 201-90401 6418796 07640135140689

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown