BEUDAMED
    FDA Adverse Event Death Summary report: N

    CENTRIMAG BLOOD PUMP

    MDR report key: 20304763 · Received September 25, 2024

    Report

    Report Number
    3003306248-2024-04433
    Event Type
    Death
    Date Received
    September 25, 2024
    Date of Event
    April 9, 2024
    Report Date
    September 27, 2024
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    QNR
    UDI-DI
    07640135140627
    PMA / PMN Number
    K020271
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEATH INFORMATION WAS REPORTED INITIALLY UNDER 3003306248-2024-00471 AND 2916596-2024-02251. 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: A DIRECT CORRELATION BETWEEN THE CENTRIMAG BLOOD PUMP AND THE REPORTED PATIENT OUTCOME COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT; HOWEVER, NO FURTHER INFORMATION WAS PROVIDED BY THE ACCOUNT. 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 CENTRIMAG BLOOD PUMP IFU LISTS POTENTIAL ADVERSE EVENTS, INCLUDING DEATH, THAT MAY BE ASSOCIATED WITH THE USE OF THE CENTRIMAG CIRCULATORY SUPPORT SYSTEM. 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. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    THE PATIENT WAS BEING TRANSITIONED TO COMFORT CARE AND WITHDRAWAL OF CARE WAS INITIATED. THE PATIENT PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1098009 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 57 YR Female Death