BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 23066531 · Received September 16, 2025

    Report

    Report Number
    2916596-2025-05909
    Event Type
    Malfunction
    Date Received
    September 16, 2025
    Date of Event
    September 2, 2025
    Report Date
    October 9, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DWA
    UDI-DI
    07640135140689
    PMA / PMN Number
    K020271
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION E: REPORTER ADDRESS LINE 1: DG. (B)(6). NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    H4 - DEVICE MANUFACTURE DATE - CORRECTION. MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF THE CENTRIMAG CONSOLE DISPLAYING A S3 ALARM WAS NOT CONFIRMED. THERE WERE NO PHOTOS OR LOG FILES SUBMITTED FOR REVIEW. THE CENTRIMAG CONSOLE, SERIAL (B)(6), WAS NOT RETURNED FOR ANALYSIS. THE PROVIDED INFORMATION INDICATED THAT THE CONSOLE HAD BEEN TRANSPORTED VIA AMBULANCE FOR THE TRANSFER OF A PATIENT BETWEEN HOSPITALS. UPON POWERING ON THE CONSOLE FOR SETUP, IT DISPLAYED AN S3 ALARM. THE ATTENDING NURSE REPLACED THE CONSOLE AND PROCEEDED WITH THE PATIENT TRANSFER. SUBSEQUENTLY, THE CONSOLE THAT HAD SHOWN THE ALERT WAS POWERED ON AGAIN, AND THE ALERT DID NOT REAPPEAR. THE CONSOLE REMAINED OPERATIONAL FOR 24 CONTINUOUS HOURS WITH A PROBE BOTTLE WITHOUT ANY ISSUES. IT WAS THEREFORE DECIDED TO KEEP THE CONSOLE IN SERVICE, RESTRICTING IT FROM AIR TRANSPORT. THERE WAS NO PATIENT INVOLVED, NO LOG FILES AVAILABLE, AND THE UNIT WOULD NOT BE RETURNED. ADDITIONAL INFORMATION PROVIDED STATED THAT THE ROOT CAUSE FOR THE ALARM WAS NOT IDENTIFIED, AS IT WAS A RANDOM ISSUE THAT OCCURRED ONLY ONCE. THEY STATED THAT THE CONSOLE WAS IN PATIENT TRANSPORT AT THE TIME, AND THE ISSUE WAS THEREFORE POSSIBLY ASSOCIATED WITH ABRUPT MOVEMENT OF THE SYSTEM. A ROOT CAUSE FOR THE REPORTED EVENT WAS UNABLE TO BE CONCLUSIVELY DETERMINED. THE PATIENT HANDBOOK CAUTIONS THE USERS TO CALL THEIR HOSPITAL CONTACTS IF THEY THINK, FOR ANY REASON, ANY PORTION OF THEIR EQUIPMENT IS NOT FUNCTIONING AS USUAL, IS BROKEN, OR THEY ARE UNCOMFORTABLE WITH THE OPERATION OF THE EQUIPMENT. 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 (REV. C) PROVIDES INFORMATION REGARDING EMERGENCIES/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 (REV. C, 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 (REV. C) SECTION 9.2 "MAINTENANCE FOLLOWING EACH PATIENT USE" STATES TO CLEAN THE EXTERIOR OF THE CONSOLE WITH BACTERICIDAL SOLUTION BY SPRAYING THE SOLUTION ON A CLOTH AND WIPING OFF THE UNIT AFTER DISCONNECTING FROM AC POWER. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THE CENTRIMAG 2ND GENERATION PRIMARY CONSOLE (SERIAL #: (B)(6)) AND THE CONSOLE WAS FOUND TO PASS ALL MANUFACTURING AND QA SPECIFICATIONS. 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 CONSOLE HAD BEEN TRANSPORTED VIA AMBULANCE FOR THE TRANSFER OF A PATIENT BETWEEN HOSPITALS. UPON POWERING ON THE CONSOLE FOR SETUP, IT DISPLAYED ALERT S3. THE ATTENDING NURSING STAFF REPLACED THE CONSOLE AND PROCEEDED WITH THE PATIENT TRANSFER. SUBSEQUENTLY, THE CONSOLE THAT HAD SHOWN THE ALERT WAS POWERED ON AGAIN, AND THE ALERT DID NOT REAPPEAR. THE CONSOLE REMAINED OPERATIONAL FOR 24 CONTINUOUS HOURS WITH A PROBE BOTTLE WITHOUT DISPLAYING ANY ALERTS OR MALFUNCTIONS. IT WAS THEREFORE DECIDED TO KEEP THE CONSOLE IN SERVICE, RESTRICTING IT FROM AIR TRANSPORT. NO PATIENT WAS INVOLVED. THERE WERE NO CONSEQUENCES ASSOCIATED. NO LOG FILES WERE AVAILABLE. THE ROOT CAUSE WAS NOT IDENTIFIED, AS IT WAS A RANDOM FAILURE THAT OCCURRED ONLY ONCE. THE CONSOLE WAS IN PATIENT TRANSPORT AT THE TIME, AND THE ISSUE WAS THEREFORE ASSOCIATED WITH ABRUPT MOVEMENT OF THE SYSTEM. THE CONSOLE REMAINED IN USE, AFTER 24 HOURS OF LOOP TESTING WITHOUT ANY FURTHER ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2680115 CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE (VAS/ECMO) CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS DWA THORATEC CORPORATION 201-90401 7549686 07640135140689

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown