BEUDAMED
    FDA Adverse Event Death Summary report: N

    CENTRIMAG BLOOD PUMP

    MDR report key: 23721521 · Received December 4, 2025

    Report

    Report Number
    2916596-2025-07808
    Event Type
    Death
    Date Received
    December 4, 2025
    Date of Event
    September 9, 2024
    Report Date
    April 8, 2026
    Manufacturer
    THORATEC CORPORATION
    Product Code
    QNR
    UDI-DI
    07640135140627
    PMA / PMN Number
    K020271
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION B3: DATE OF DEATH WAS NOT PROVIDED. MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE CENTRIMAG BLOOD PUMP AND THE REPORTED EVENTS AND SUBSEQUENT PATIENT OUTCOME COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. IT WAS ADDITIONALLY COMMUNICATED THAT THE SERIAL LOT/NUMBER OF THE CENTRIMAG BLOOD PUMP WAS NOT AVAILABLE, AS THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL AFTER THE REPORTED EVENT. 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), IS CURRENTLY AVAILABLE. THE CURRENT REVISIONS OF THE IFU CAN ALSO BE FOUND ON THE ELECTRONIC IFU (EIFU) PAGE OF THE ABBOTT WEBSITE. THE IFU LISTS LIMB ISCHEMIA AND DEATH AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE CENTRIMAG CIRCULATORY SUPPORT SYSTEM. THIS IFU ALSO PROVIDES THE FOLLOWING WARNINGS AND CAUTIONS: IFU WARNING #2: BACK-UP COMPONENTS MUST ALWAYS BE AVAILABLE. IFU WARNING #12: FREQUENT PATIENT AND DEVICE MONITORING IS RECOMMENDED. DO NOT LEAVE THE DEVICE UNATTENDED DURING USE. IFU CAUTION #5: THIS DEVICE SHOULD ONLY BE USED BY PERSONS THOROUGHLY TRAINED IN EXTRACORPOREAL CIRCULATION PROCEDURES. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    A. PATIENT INFORMATION WAS NOT PROVIDED BY THE 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 ADDITIONALLY REPORTED THAT THE ISCHEMIA WAS NOT DEVICE OR THERAPY RELATED. THE DEVICE OPERATED AS EXPECTED. THE ISCHEMIA DID NOT RESOLVE AS THE PATIENT EXPIRED DUE TO OTHER COMPLICATIONS, AND STOPPING ALL THERAPIES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD ISCHEMIA OF THE LEFT FOOT THAT REQUIRED MEDICAL INTERVENTION TO PREVENT INJURY OR PERMANENT DISABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79289 CENTRIMAG BLOOD PUMP BLOOD PUMP FOR ECMO, LONG-TERM (> 6 HOURS) USE QNR THORATEC CORPORATION 102953 07640135140627

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death| R