BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC CENTRIMAG PRIMARY CONSOLE

    MDR report key: 6998718 · Received November 3, 2017

    Report

    Report Number
    2916596-2017-02588
    Event Type
    Injury
    Date Received
    November 3, 2017
    Date of Event
    October 9, 2017
    Report Date
    June 26, 2018
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    DWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). APPROXIMATE AGE OF DEVICE- 4 YEARS AND 11 MONTHS (CALCULATED FROM THE DATE OF MANUFACTURE TO THE DATE OF THE EVENT.). THE DEVICE WAS RETURNED FOR INVESTIGATION. THE EVALUATION IS NOT YET COMPLETE. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    MOTOR EVALUATED UNDER MEDWATCH MFR# 2916596-2017-02588. THE RETURNED EXTRACORPOREAL CIRCULATORY SUPPORT (CENTRIMAG) PRIMARY CONSOLE WAS EVALUATED AND TESTED BY TECHNICAL SERVICE. THE CONSOLE'S COVER WAS REMOVED TO INSPECT ALL INTERIOR CABLE ASSEMBLES, WHICH WERE FOUND TO BE SECURE AND IN GOOD CONDITION. THE COVER WAS RE-INSTALLED AND THE UNIT WAS CONNECTED TO A LAB OWNED CENTRIMAG MOCK LOOP AND TO ITS ASSOCIATED CENTRIMAG MOTOR. THE UNIT RAN FOR SEVERAL DAYS WITHOUT PRODUCING ANY ALARMS OR ISSUES. AS A RESULT, THE REPORTED EVENT COULD NOT BE CONFIRMED. THE CONSOLE AND MOTOR FUNCTIONED AS INTENDED. HOWEVER, IT WAS NOTED THAT THE CONSOLE'S BATTERY HAD EXPIRED AND THE CONSOLE SOFTWARE NEEDED TO BE UPGRADED. A NEW BATTERY WAS INSTALLED AND THE SOFTWARE WAS UPGRADED TO THE LATEST VERSION. THE CONSOLE WAS TESTED PER THE CENTRIMAG 2ND GEN PRIMARY CONSOLE SERVICE PROCESS AND THE UNIT PASSED ALL TESTS. THE DEVICE WAS RETURNED TO THE CUSTOMER SITE. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED DURING THE INVESTIGATION NOR CORRELATED TO A DEVICE RELATED ISSUE. REPORTS OF SIMILAR EVENTS WILL CONTINUE TO BE TRACKED AND MONITORED. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS SUPPORTED BY AN EXTRACORPOREAL CIRCULATORY SUPPORT DEVICE. IT WAS REPORTED THAT THE DEVICE RECEIVED A MOTOR DISCONNECTED ERROR AFTER NINE DAYS OF SUPPORT. THE PATIENT BECAME HYPOTENSIVE FOR APPROXIMATELY 5 MINUTES. THE PATIENT MAINTAINED A SYSTOLIC BLOOD PRESSURE OF 70 MMHG UNTIL THE SYSTEM WAS ABLE TO BE EMERGENTLY CHANGED TO A BACKUP CONSOLE AND MOTOR. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780662 THORATEC CENTRIMAG PRIMARY CONSOLE CENTRIMAG PRIMARY CONSOLE DWA THORATEC SWITZERLAND GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention