BEUDAMED
    FDA Adverse Event Death Summary report: N

    CENTRIMAG 2ND GENERATION PRIMARY CONSOLE

    MDR report key: 9606570 · Received January 20, 2020

    Report

    Report Number
    2916596-2020-00279
    Event Type
    Death
    Date Received
    January 20, 2020
    Date of Event
    December 21, 2019
    Report Date
    March 20, 2020
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    DWA
    PMA / PMN Number
    K131179
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE CENTRIMAG MOTOR AND 2ND GEN PRIMARY CONSOLE USED DURING THE REPORTED EVENT WERE NOT RETURNED FOR ANALYSIS. REQUESTS FOR PRODUCT RETURN AND DEVICE INFORMATION WERE SENT AND IT WAS REPORTED THAT NO PRODUCT WOULD BE RETURNED AS BOTH THE HEARTMATE 3 AND CENTRIMAG SYSTEMS OPERATED AS INTENDED. IT WAS ALSO REPORTED THAT THE SERIAL NUMBERS OF THE DEVICES USED DURING THE EVENT WOULD NOT BE PROVIDED. AS A RESULT, THE ROOT CAUSE OF THE REPORTED PATIENT DEATH COULD NOT BE CORRELATED TO A DEVICE RELATED ISSUE. IT WAS REPORTED THAT THE CAUSE OF DEATH WAS WORSENING SHOCK AND MULTISYSTEM ORGAN FAILURE. REPORTS OF SIMILAR EVENTS WILL CONTINUE TO BE TRACKED AND MONITORED. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED. THE PATIENT'S CAUSE OF DEATH WAS WORSENING SHOCK AND MULTISYSTEM ORGAN FAILURE. HM3 AND THE CENTRIMAG WERE FUNCTIONING BUT PATIENT CONTINUED TO DETERIORATE. NO FURTHER OR ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69536 CENTRIMAG 2ND GENERATION PRIMARY CONSOLE CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS DWA THORATEC SWITZERLAND GMBH 201-90411

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death