BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 6106111 · Received November 16, 2016

    Report

    Report Number
    2916596-2016-02237
    Event Type
    Injury
    Date Received
    November 16, 2016
    Date of Event
    October 25, 2016
    Report Date
    July 20, 2017
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE UNIQUE IDENTIFIER (UDI)  DEVICE WAS MANUFACTURED PRIOR TO THE UDI LABELING IMPLEMENTATION. APPROXIMATE AGE OF DEVICE - 2 YEARS, 9 MONTHS. THE PATIENT REMAINS ON LVAD SUPPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL/CORRECTED INFORMATION: THE REPORT OF A PUMP STOP AND DRIVELINE DISCONNECT EVENT WAS CONFIRMED THROUGH THE EVALUATION OF THE SUBMITTED SYSTEM CONTROLLER LOG FILE. A PUMP STOP WITH THE CORRESPONDING LOW SPEED HAZARD ALARM CAPTURED ON (B)(4) 2016 AT 06:24, WHILE THE SYSTEM WAS ON BATTERY POWER. THE DRIVELINE DISCONNECT ALARM WAS ACTIVE DURING THIS EVENT AND PERSISTED THROUGH TO THE END OF THE LOG FILE WHICH ENDS ON (B)(4) 2016 AT 07:28. THE OBSERVED PUMP STOP/DRIVELINE DISCONNECT EVENT APPEARED CONSISTENT WITH A POTENTIAL DRIVELINE ISSUE; HOWEVER, A SPECIFIC CAUSE FOR THE EVENT COULD NOT BE CONCLUSIVELY DETERMINED WITHOUT A FULL DEVICE EVALUATION. THE PUMP APPEARED TO HAVE OPERATED AS INTENDED PRIOR TO THE CAPTURED PUMP STOP/DRIVELINE DISCONNECT EVENT. X-RAY IMAGES OF THE DRIVELINE APPEARED INCONCLUSIVE FOR ANY AREA OF CONCERN. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (B)(6) 2014. IT WAS REPORTED THAT THE PATIENT'S LVAD DRIVELINE WAS TWISTED. LOG FILE REVIEW BT THE MANUFACTURER'S TECHNICAL SERVICES CONFIRMED PUMP STOPPAGES ON BATTERY POWER. IMAGES OF THE DRIVELINE SENT TO THE TECHNICAL SERVICE REPRESENTATIVE FOR REVIEW DID NOT SHOW ANY AREAS OF CONCERN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT BEEN PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE PATIENT HAD OBSERVED A RED HEART ALARM ON (B)(6) 2016 AND INDICATED THAT THE SYSTEM CONTROLLER STATED "CONNECT DRIVELINE" ON THE DISPLAY SCREEN. THE PATIENT CONFIRMED THAT THE DRIVELINE WAS CONNECTED AND DENIED CHEST PAIN, SHORTNESS OF BREATH, AND DIZZINESS. WHEN SEEN IN THE EMERGENCY DEPARTMENT, EXAMINATION BY AUSCULTATION DETERMINED THAT THE PUMP WAS OFF; HOWEVER, THE PATIENT WAS ASYMPTOMATIC. THE RISK OF THROMBUS WAS DETERMINED TO BE TOO HIGH TO RESTART THE PUMP; THEREFORE, THE DECISION WAS MADE TO NOT RESTART THE PUMP. IT WAS REPORTED THAT THE PATIENT WAS PULSATILE AND ABLE TO MAINTAIN A BLOOD PRESSURE. AN ECHOCARDIOGRAM SHOWED THAT THE PATIENT HAD AN EJECTION FRACTION OF 15 PERCENT. INTERROGATION OF THE SYSTEM CONTROLLER REPORTEDLY SHOWED LOW FLOW AND LOW SPEED ALARMS FOLLOWED BY A DRIVELINE DISCONNECT ALARM AND PUMP STOP. IT WAS REPORTED THAT THE PATIENT WAS TRANSFERRED TO THE CARDIAC INTENSIVE CARE UNIT FOR 24 HOURS OF MONITORING AFTER WHICH THE DECISION WAS MADE TO NOT EXCHANGE THE PUMP DUE TO THE PATIENT¿S HISTORY EXTREME NON-COMPLIANCE. THE PUMP WAS NOT EXPLANTED. IT WAS REPORTED THAT THE DRIVELINE WAS SIMPLY A CUT AND THE WOUND WAS SURGICALLY CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755949 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization| R