BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTRIMAG BLOOD PUMP

    MDR report key: 23547846 · Received November 13, 2025

    Report

    Report Number
    3003306248-2025-00321
    Event Type
    Injury
    Date Received
    November 13, 2025
    Date of Event
    October 13, 2025
    Report Date
    December 29, 2025
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    QNR
    UDI-DI
    07640135140627
    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: CLOTTING WAS UNABLE TO BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION, AND NO PHOTOS WERE SUBMITTED. A DIRECT CORRELATION BETWEEN THE REPORTED EVENTS AND THE CENTRIMAG BLOOD PUMP COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. IT WAS REPORTED THAT FLOW INITIALLY HAD TO BE SET QUITE HIGH IN ORDER TO GET ANY FLOW AND WAS THEN ABLE TO COME BACK DOWN A BIT. FLOW WAS LOST AGAIN COMPLETELY A FEW HOUR LATER, AND THE CENTRIMAG CIRCUIT WAS EXCHANGED. THERE WAS SOME CLOTTING IN THE VENOUS CANNULA. THERE WAS NOTED TO BE A CORRELATION IN HEMODYNAMICS. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER REGARDING THE EVENT; HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED. THE CENTRIMAG BLOOD PUMP WAS NOT RETURNED FOR EVALUATION. THE SERIAL 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) LISTS VENOUS THROMBOEMBOLISM AND ARTERIAL NON-CNS (NON-CENTRAL NERVOUS SYSTEM) THROMBOEMBOLISM AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE CENTRIMAG BLOOD PUMP. THE IFU CONTAINS THE FOLLOWING ADDITIONAL WARNINGS AND CAUTIONS: IFU WARNING #7: IT IS INTENDED THAT SYSTEMIC ANTICOAGULATION BE UTILIZED WHILE THIS DEVICE IS IN USE. ANTICOAGULATION LEVELS SHOULD BE DETERMINED BY THE PHYSICIAN BASED ON RISKS AND BENEFITS TO THE PATIENT. 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 #9: MONITOR CAREFULLY FOR ANY SIGNS OF OCCLUSION THROUGHOUT THE CIRCUIT. IFU CAUTION #15: ALWAYS HAVE A BACKUP CENTRIMAG PUMP, CONSOLE, MOTOR, AND ACCESSORIES AVAILABLE FOR USE. THE CURRENT REVISIONS OF THE INSTRUCTIONS FOR USE (IFU) AND OPERATION MANUAL CAN ALSO BE FOUND ON THE ELECTRONIC IFU PAGE OF THE ABBOTT WEBSITE. 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 CONSOLE WAS EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1983653 CENTRIMAG BLOOD PUMP BLOOD PUMP FOR ECMO, LONG-TERM (> 6 HOURS) USE QNR THORATEC SWITZERLAND GMBH 102953 07640135140627

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention