BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC CENTRIMAG PRIMARY CONSOLE

    MDR report key: 4253070 · Received November 13, 2014

    Report

    Report Number
    2916596-2014-02065
    Event Type
    Injury
    Date Received
    November 13, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 16, 2014
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    DWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE-RELATED ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE VERIFIED THROUGH THIS EVALUATION AS THE CMAG PRIMARY CONSOLE WAS NOT RETURNED TO THORATEC FOR EVALUATION; HOWEVER, THE ACCOUNT COMMUNICATED THAT THE HOSPITAL STAFF WERE AWARE OF THE CONSOLE'S LOW BATTERY CONDITION AND WERE TRYING TO GET THE PATIENT TO BED PRIOR TO THE PUMP STOPPAGE. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    USAGE OF THE DEVICE: THE USAGE OF THE PRIMARY CONSOLE IS NOT KNOWN TO THE MANUFACTURER AS THE DEVICE IS NOT LABELED FOR SINGLE USE. TO DATE, THE SERIAL NUMBER HAS NOT BEEN PROVIDED FROM THE HOSPITAL. THE APPROXIMATE AGE OF THE DEVICE IS UNKNOWN. THE DEVICE REMAINS IN USE AT THE HOSPITAL. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS BEING SUPPORTED WITH A VENTRICULAR ASSIST DEVICE FOR ACUTE SUPPORT. THE PATIENT WAS WALKING AROUND WITH NURSES FOR ABOUT 2 HOURS ON THE UNIT'S BATTERY POWER WHEN SUDDENLY THE PUMP STOPPED AND THE CONSOLE SHUT OFF. THE NURSES WERE REPORTEDLY AWARE OF THE CONSOLE'S LOW BATTERY CONDITION, AND THEY WERE TRYING TO GET THE PATIENT TO THE BED PRIOR TO THE PUMP STOPPAGE. WHEN THE PUMP STOPPED, THE PATIENT FELL FORWARD TO THE GROUND. THE PATIENT IS SCHEDULED FOR A CT SCAN AND CHEST X-RAY. AFTER THE EVENT, THE VAD COORDINATOR DID STATE THAT THE PUMP IN USE DURING THE EVENT WAS CHARGED OVER NIGHT. THE CONSOLE INDICATED THAT THE BATTERY WAS FULLY CHARGED AND APPEARS TO BE FUNCTIONING. NO ERROR MESSAGE IS PRESENT. THE CENTER WILL PUT THE CONSOLE BACK INTO SERVICE. THE PATIENT IS DOING WELL AFTER THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733763 THORATEC CENTRIMAG PRIMARY CONSOLE DWA: CENTRIMAG PRIMARY CONSOLE DWA THORATEC SWITZERLAND GMBH 102954

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention