BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3780695 · Received April 21, 2014

    Report

    Report Number
    2916596-2014-00605
    Event Type
    Injury
    Date Received
    April 21, 2014
    Date of Event
    March 23, 2014
    Report Date
    March 24, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT OF LOW SPEED, LOW FLOW, AND DRIVELINE DISCONNECT ALARMS WERE CONFIRMED UPON REVIEW OF THE SUBMITTED SYSTEM CONTROLLER LOG FILES; HOWEVER, A ROOT CAUSE FOR THE ALARMS COULD NOT BE DETERMINED AS THE PUMP WAS NOT RETURNED FOR EVALUATION. IT WAS COMMUNICATED THAT THE PATIENT REMAINED ONGOING ON PUMP SUPPORT WITH AN UNGROUNDED PATIENT CABLE. A REVIEW OF DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE PT REMAINS ONGOING ON VAD SUPPORT AND NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PT RECEIVED A NEW POCKET CONTROLLER AND WAS SUBSEQUENTLY ADMITTED TO THE HOSPITAL THIS PAST SUNDAY FOR SYNCOPE. REPORTEDLY, THE PT HAS CANCER AND IS CURRENTLY BEING TREATED. THE PT HAS RECEIVED RECENT BLOOD TRANSFUSIONS; HER LABS ON ADMISSION WERE 7.2 AND 21.8. IT WAS REPORTED THAT THE PATIENT'S HEMOGLOBIN AND HEMATOCRIT DURING THE MORNING WAS 6.6 AND 20.5. THE PT WAS SUPPLIED WITH BLOOD. LOG FILES WERE SUBMITTED FOR EVALUATION AFTER THE PT REPORTEDLY BEGAN EXPERIENCING LOW SPEED, DRIVELINE DISCONNECT, AND LOW FLOW ALARMS DURING THE MORNING. THE PT WAS SYMPTOMATIC AND THE NURSE AT THE HOSPITAL EVALUATED THE PATIENT'S DRIVELINE. IT WAS NOTED THAT EVERYTHING WAS INTACT AND THERE WERE NO DISCONNECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241397 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 104107

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention