BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 3960795 · Received June 10, 2014

    Report

    Report Number
    0002916596-2014-00951
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 12, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM CONTROLLER WAS RETURNED TO THE MANUFACTURER, AND IS CURRENTLY BEING ANALYZED. 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 IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PATIENT REPORTED A PUMP STOPPAGE WHEN AT HOME, AND THE SYSTEM CONTROLLER WAS EXCHANGED WITH ASSISTANCE FROM HIS WIFE. FURTHER DETAILS OF THE EVENT WERE PROVIDED BY THE VAD COORDINATOR. THE PATIENT CALLED THE OFFICE TO REPORT THAT HE HAD A RED HEART ALARM AFTER CHANGING BATTERIES. THE PATIENT REPORTED THAT WHEN HE CAME TO CLINIC EARLIER THAT DAY HE HAD NUMEROUS LOW VOLTAGE ALERTS. THE PATIENT'S BATTERIES WERE SENT TO THE HOSPITAL'S BIO-MEDICAL ENGINEER TO BE CHECKED AND ALL WERE OK, BUT ONE NEEDED TO BE CALIBRATED. THE PATIENT WAS PROVIDED 8 LOANER BATTERIES (IN CLINIC) DUE TO THE ALARMS THAT OCCURRED WHILE CHANGING HIS BATTERIES. THE PATIENT STATED THAT HE SWITCHED TO THE LOANER BATTERIES ISSUED IN THE CLINIC AND THEN TRAVELED HOME (LIVES ABOUT 1 HOUR AWAY). WHEN HE ARRIVED HOME HIS BLACK POWER SIDE HAD 3 FUEL LIGHTS AND THE WHITE POWER SIDE HAT 5 FUEL LIGHTS. THE PATIENT CHANGED THE BLACK POWER SIDE BATTERY AND THEN A RED HEART ALARM OCCURRED. HE QUICKLY ATTACHED HIS BLACK POWER LEAD TO BATTERY AND THEN TO THE POWER MODULE, AND ONCE HE WAS CONNECTED TO THE POWER MODULE THE ALARM WAS RESOLVED. THE SYSTEM CONTROLLER WAS CONNECTED TO THE POWER MODULE AND BOTH POWER CABLES WERE INDEPENDENTLY MANIPULATED AND THERE WAS NO NOTED CHANGE IN THE SYSTEM VALUES, AND NO ALARMS OCCURRED. THE PATIENT CALLED THE VAD OFFICE AND WAS INSTRUCTED TO COME BACK TO CLINIC FOR ASSESSMENT. THE PATIENT'S ORIGINAL BATTERIES WERE RETURNED TO HIM. THE VAD COORDINATOR HAD THE PATIENT LIE DOWN ON THE EXAMINING TABLE AND EXCHANGED THE SYSTEM CONTROLLER WITH THE PATIENT'S WIFE. THE PATIENT TOLERATED THE PROCEDURE WELL AND NO DISTRESS WAS NOTED, AND HIS WIFE WAS ABLE TO PERFORM THE EXCHANGE WITHOUT ANY ISSUES. THE PATIENT'S BATTERY CLIPS WERE EXCHANGED AS WELL. THE PATIENT STATED THAT HE CLEANS ALL THE BATTERY CONTACTS EVERY. THE PATIENT'S SYSTEM CONTROLLER WAS RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337035 HEARTMATE II SYSTEM CONTROLLER DSQ: LVAD SYSTEM CONTROLLER DSQ THORATEC CORP. 103696

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other