BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTRIMAG BLOOD PUMP

    MDR report key: 19862416 · Received July 30, 2024

    Report

    Report Number
    2916596-2024-04821
    Event Type
    Injury
    Date Received
    July 30, 2024
    Date of Event
    June 10, 2024
    Report Date
    August 20, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    QNR
    PMA / PMN Number
    K020271
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B2 OUTCOMES ATTRIBUTED TO ADVERSE: CORRECTED. MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE CENTRIMAG DEVICE AND THE REPORTED MULTI SYSTEM ORGAN FAILURE AND PATIENT OUTCOME COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS 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 OUTSIDE OF UNITED STATES (OUS) CENTRIMAG BLOOD PUMP INSTRUCTIONS FOR USE (IFU) (REV. A) LIST WARNINGS AND CAUTIONS REGARDING THE USE OF THE CENTRIMAG CIRCULATORY SUPPORT SYSTEM: IFU WARNING #9: POSSIBLE SIDE EFFECTS INCLUDE END ORGAN DYSFUNCTION. THIS IS A POTENTIAL SIDE EFFECT WITH ALL MECHANICAL CIRCULATORY SUPPORT SYSTEMS. IFU WARNING #17: 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 #14: ALWAYS HAVE A SPARE CENTRIMAG VAD, CENTRIMAG BACK-UP CONSOLE AND SPARE EQUIPMENT READILY AVAILABLE FOR CHANGE. 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 COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED PNEUMONIA WITH NO BACTERIAL OR VIRAL CAUSE DETECTED. THIS LED TO RIGHT VENTRICULAR FAILURE WHICH WAS TREATED WITH A TEMPORARY RIGHT VENTRICULAR ASSIST DEVICE (RVAD), BUT THE PATIENT DEVELOPED MULTIPLE ORGAN FAILURE THAT LED TO THE PATIENT PASSING AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240912 CENTRIMAG BLOOD PUMP BLOOD PUMP FOR ECMO, LONG-TERM (> 6 HOURS) USE QNR THORATEC CORPORATION 102953

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other| L