BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC CENTRIMAG PRIMARY CONSOLE

    MDR report key: 6938570 · Received October 10, 2017

    Report

    Report Number
    2916596-2017-02292
    Event Type
    Injury
    Date Received
    October 10, 2017
    Date of Event
    September 14, 2017
    Report Date
    December 12, 2017
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    DWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CENTRIMAG PRIMARY CONSOLE WAS RETURNED AND EVALUATED BY A MANUFACTURER¿S TECHNICAL SERVICES REPRESENTATIVE. THE RECEIVED UNIT WAS CHARGED OVERNIGHT. A FUNCTIONAL CHECKOUT WAS PERFORMED AND FOUND THAT THE UNIT RAN FOR THREE MINUTES ON BATTERY BEFORE RETURNING A "BATTERY BELOW MINIMUM" MESSAGE ON THE DISPLAY. THE UNIT WAS INSPECTED AND IT WAS FOUND THAT THE BATTERY PACK WAS PAST DUE FOR REPLACEMENT; THE LAST BATTERY PACK REPLACEMENT WAS (B)(6) 2014. THE BATTERY PACK WAS REPLACED WITH A NEW ONE AND THE REQUIRED BATTERY MAINTENANCE PROCESS WAS PERFORMED. A FULL FUNCTIONAL CHECKOUT WAS PERFORMED AND THE UNIT PASSED ALL TESTS. THE TESTED UNIT WAS RETURNED TO THE CUSTOMER SITE. PERIODIC INTERNAL RE-CHARGEABLE BATTERY PACK REPLACEMENT AND MAINTENANCE IS AN ASPECT OF RECOMMENDED PREVENTIVE MAINTENANCE. THE INTERNAL RECHARGEABLE BATTERY PACK MUST BE REPLACED EVERY 2 YEARS AND BATTERY MAINTENANCE SHOULD BE PERFORMED ONCE EVERY 6 MONTHS. PRIOR TO TRANSPORTATION THE INTERNAL BATTERIES MUST BE VERIFIED AS FULLY CHARGED AND TO UNPLUG AND TEST THE UNIT'S ABILITY TO OPERATE ON BATTERY PRIOR TO TRANSPORT. A BACKUP CONSOLE WITH EXTRA SETS OF BATTERY MODULES SHOULD ALSO BE AVAILABLE. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THE DEVICE MET APPLICABLE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE PATENT'S DATE OF BIRTH AND AGE WERE NOT PROVIDED. THE PATIENT¿S SEX WAS NOT PROVIDED. THE PATIENT¿S WEIGHT WAS NOT PROVIDED. UNIQUE IDENTIFIER (UDI) # (DEVICE IDENTIFIER): DEVICE WAS MANUFACTURED PRIOR TO THE UDI LABELING IMPLEMENTATION. 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.

    Description of Event or Problem · 1

    THE PATIENT WAS SUPPORTED WITH AN EXTRACORPOREAL CIRCULATORY SUPPORT DEVICE. IT WAS REPORTED THAT A PUMP STOPPAGE OCCURRED WHILE THE DEVICE WAS SUPPORTING THE PATIENT. IT WAS REPORTED THAT THE PATENT'S STATUS WAS NOT CLEAR. THE EQUIPMENT WAS RETURNED FOR BATTERY MAINTENANCE. FURTHER INFORMATION WAS REQUESTED, BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714814 THORATEC CENTRIMAG PRIMARY CONSOLE CENTRIMAG PRIMARY CONSOLE DWA THORATEC SWITZERLAND GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention