BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTRIMAG BLOOD PUMP

    MDR report key: 22481739 · Received July 11, 2025

    Report

    Report Number
    3003306248-2025-00205
    Event Type
    Injury
    Date Received
    July 11, 2025
    Date of Event
    September 26, 2024
    Report Date
    September 5, 2025
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    QNR
    UDI-DI
    07640135140627
    PMA / PMN Number
    K020271
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    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

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE REPORTED EVENTS AND THE CENTRIMAG BLOOD PUMP COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE LOT NUMBER OF THE DEVICE WAS NOT REPORTED. THE CENTRIMAG BLOOD PUMP INSTRUCTIONS FOR USE (IFU) LISTS CARDIAC ARRHYTHMIAS AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE CENTRIMAG CIRCULATORY SUPPORT SYSTEM UNDER ¿ADVERSE EVENTS¿. THIS 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. THE CURRENT REVISIONS OF THE INSTRUCTIONS FOR USE (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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT RECEIVED A CENTRIMAG POST LEFT VENTRICULAR ASSIST DEVICE (LVAD) PLACEMENT. THE PATIENT WAS IMPLANTED WITH THE LVAD ON (B)(6) 2024. IT WAS REPORTED THAT THE LVAD WAS FUNCTIONING AS INTENDED AND THAT THE CENTRIMAG WAS PLACED DUE TO ACUTE POST-OPERATIVE RIGHT HEART FAILURE (RHF) WITH VASOPLEGIA. IT WAS NOTED THAT THE PATIENT HAD MILD-MODERATELY REDUCED RV FUNCTION PRIOR TO IMPLANT SEEN IN A PREVAD ECHOCARDIOGRAM (ECHO). THE DAY BEFORE THE PATIENT HAD AN IMPELLA RP FLEX INSERTED WITH A SLIGHT INCREASE ON FLOWS. IT WAS DECIDED TO TRANSITION THE PATIENT TO A CENTRIMAG ON (B)(6) 2024. AFTER UPGRADE TO RVAD CENTRIMAG SUPPORT THE PATIENTS, LOW FLOWS IMPROVED. IT WAS NOTED THAT THE PATIENT WAS STABLE. THERE WERE NO DEVICE RELATED ISSUES. THE DEVICE WAS NOT THOUGH TO HAVE CONTRIBUTED TO THE RIGHT HEART FAILURE. LOG FILES WERE UNAVAILABLE. THE PATIENT DEVELOPED MULTIFOCAL PNEUMONIA REQUIRING REINTUBATION ON (B)(6) 2024. THE PATIENT ALSO EXPERIENCED VENTRICULAR FIBRILLATION WITH 1 SHOCK ON (B)(6) 2024. THE FAMILY OF THE PATIENT DID NOT FEEL ONGOING CARE WAS CONSISTENT WITH PATIENTS WISHES AND DEVICE SUPPORT WAS DISCONTINUED ON (B)(6) 2024. THE PATIENT PASSED AWAY (B)(6) 2024.THE DEVICE WAS REPORTEDLY OPERATING AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652994 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 66 YR Female Required Intervention| H