BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3822700 · Received February 12, 2014

    Report

    Report Number
    2916596-2014-00168
    Event Type
    Malfunction
    Date Received
    February 12, 2014
    Date of Event
    January 14, 2014
    Report Date
    January 16, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT REMAINS ONGOING WITH LVAD SUPPORT; THEREFORE THE LVAD COULD NOT BE ANALYZED. THE SYSTEM CONTROLLER WAS RECEIVED FOR EVALUATION. THE REPORT OF LOW SPEED EVENTS, MOTOR STOP EVENTS, AND POWER ELEVATIONS WERE CONFIRMED BASED ON THE EVALUATION OF THE SYSTEM CONTROLLER LOG FILE SUBMITTED BY THE CUSTOMER. ADDITIONALLY, THE REPORTED EVENTS OF SYSTEM STOP AND POWER ELEVATIONS WERE CONFIRMED THROUGH ANALYSIS OF A LOG FILE DOWNLOADED FROM THE RETURNED SYSTEM CONTROLLER. HOWEVER, FUNCTIONAL TESTING OF THE RETURNED SYSTEM CONTROLLER USING TEST LABORATORY EQUIPMENT FOUND THE CONTROLLER TO FUNCTION AS INTENDED. NO ATYPICAL ALARM CONDITIONS COULD BE INDUCED DURING THE INVESTIGATION AND THE EVENTS CAPTURED IN THE LOG FILE COULD NOT BE REPRODUCED OR CORRELATED TO THE SYSTEM CONTROLLER. NO FURTHER ISSUES HAVE BEEN REPORTED AFTER THE SYSTEM CONTROLLER WAS EXCHANGED. 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 LVAD SUPPORT. NO FURTHER ISSUES HAVE BEEN REPORTED AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. THE CLINICIAN AT THE HOSPITAL REPORTED THAT THE PT PRESENTED WITH SPEED CHANGES AND PUMP STOPPAGE ALARMS. A REVIEW OF THE SUBMITTED LOG FILE CONFIRMED A LOW SPEED ADVISORY FOLLOWED BY PUMP STOPPAGE AND POWER ELEVATIONS. THE PT'S DRIVELINE WAS PHYSICALLY MANIPULATED DURING TROUBLESHOOTING; HOWEVER, NO ALARMS WERE OBSERVED. THE DRIVELINE WAS FOUND TO BE NORMAL W/O ANY EVIDENCE OF KINKING. IT WAS REPORTED THAT THE PT EXPERIENCED THE ALARMS WHILE SHE WAS LYING IN BED. THE PT'S SYSTEM CONTROLLER WAS SUBSEQUENTLY EXCHANGED AND THE PT WAS DISCHARGED. THERE WAS NO INDICATION THAT THE REPORTED ISSUE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93019 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106015 134205

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR