BEUDAMED
    FDA Adverse Event Death Summary report: N

    CENTRIMAG BLOOD PUMP

    MDR report key: 23295947 · Received October 15, 2025

    Report

    Report Number
    3003306248-2025-00288
    Event Type
    Death
    Date Received
    October 15, 2025
    Date of Event
    September 29, 2025
    Report Date
    January 15, 2026
    Manufacturer
    THORATEC CORPORATION
    Product Code
    QNR
    UDI-DI
    07640135140627
    PMA / PMN Number
    K020271
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED LOW FLOW ALARMS WERE UNABLE TO BE CONFIRMED AS NO LOG FILES WERE AVAILABLE. A SPECIFIC CAUSE FOR THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED, AND A DIRECT CORRELATION BETWEEN THE REPORTED EVENTS AND THE CENTRIMAG PUMP COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION REGARDING THIS EVENT WERE SUBMITTED TO THE ACCOUNT; HOWEVER, NO RESPONSE HAS BEEN RECEIVED AT THIS TIME, AND THE CENTRIMAG PUMP WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER OR OTHER IDENTIFYING INFORMATION OF THE PRODUCT WAS NOT REPORTED AND WAS NOT ABLE TO BE DETERMINED DURING THE INVESTIGATION. THE CENTRIMAG BLOOD PUMP INSTRUCTIONS FOR USE (IFU) (REV. C) IS CURRENTLY AVAILABLE. THE IFU LISTS DEATH AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE CENTRIMAG CIRCULATORY SUPPORT SYSTEM UNDER ¿ADVERSE EVENTS.¿ THE IFU ALSO PROVIDES THE FOLLOWING WARNINGS AND CAUTIONS: IFU WARNING #10: FREQUENT PATIENT AND DEVICE MONITORING IS RECOMMENDED. IFU CAUTION #2: THIS DEVICE SHOULD ONLY BE USED BY PERSONS THOROUGHLY TRAINED IN EXTRACORPOREAL CIRCULATION PROCEDURES. IFU CAUTION #15: ALWAYS HAVE A BACKUP CENTRIMAG PUMP, CONSOLE, MOTOR, AND ACCESSORIES AVAILABLE FOR USE. THE CENTRIMAG OPERATING MANUAL (REV. E) IS CURRENTLY AVAILABLE. SECTION 12.1 ENTITLED "APPENDIX I ¿ CONSOLE ALARMS AND ALERTS" IN THIS IFU CONTAINS A LIST OF CONSOLE ALARMS AND ALERTS, INCLUDING THE F2 AND F3 FLOW ALERTS, AS WELL AS APPROPRIATE OPERATOR RESPONSE TO THESE EVENTS. THE CURRENT REVISIONS OF THE IFU AND OPERATION MANUAL CAN ALSO BE FOUND ON THE ELECTRONIC IFU (EIFU) PAGE OF THE ABBOTT WEBSITE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    SECTION D4: DEVICE LOT NUMBER WAS NOT PROVIDED, AND EXPIRATION DATE CANNOT BE DETERMINED. THE PRIMARY UDI NUMBER IN D4 IS UPDATED WITH ALL OF THE CURRENT INFORMATION AVAILABLE. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    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 PATIENT WAS ON CENTRIMAG (CMAG) MECHANICAL CIRCULATORY SUPPORT WHEN THE CONSOLE STOPPED WORKING. THE CUSTOMER SWAPPED OUT THE CMAG CONSOLE, MOTOR, AND MONITOR FOR A NEW SET AND THE CUSTOMER WAS PLACED BACK ON SUPPORT. IT WAS COMMUNICATED ON (B)(6)2025 THAT THE PATIENT PASSED AWAY. IT WAS POSSIBLE THAT THE DEVICE ISSUE IMPACTED THE PATIENT.

    Description of Event or Problem · 0

    IT WAS CONFIRMED THAT THE PATIENT PASSED AWAY ON (B)(6) 2025, AND THEY HAD MULTIPLE COMORBIDITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2020962 CENTRIMAG BLOOD PUMP BLOOD PUMP FOR ECMO, LONG-TERM (> 6 HOURS) USE QNR THORATEC CORPORATION 102953 07640135140627

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Male Death