BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 3936056 · Received June 23, 2014

    Report

    Report Number
    2916596-2014-01034
    Event Type
    Injury
    Date Received
    June 23, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 21, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION 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.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF A SYSTEM STOP AND PI EVENTS WAS CONFIRMED VIA THE PATIENT¿S EVENT HISTORY ANALYSIS BUT COULD NOT BE CORRELATED TO THE RETURNED SYSTEM CONTROLLER. THE PATIENT¿S EVENT HISTORY CAPTURED APPROXIMATELY 7 DAYS OF DATA DATED FROM (B)(6) 2014 TO (B)(6) 2014 (ACCORDING TO THE TIME STAMP). ON (B)(6) 2014 AT 12:43 EVENTS WERE CAPTURED WHERE THE PUMP SPEED DROPPED BELOW THE LOW SPEED LIMIT AND THEN THE SPEED WAS CAPTURED AT 0 RPM. THE SYSTEM STOP APPEARS TO HAVE HAD A DURATION OF APPROXIMATELY 2 SECONDS. ALTHOUGH A TIME BASE FAULT WAS CAPTURED AS ACTIVE DURING THESE EVENTS, THIS FAULT STATUS COULD NOT CONCLUSIVELY BE CORRELATED TO THE SYSTEM STOP EVENTS. AFTER THE SYSTEM STOP, THE SYSTEM CONTROLLER REMAINED AT THE SET SPEED UNTIL THE DRIVELINE WAS DISCONNECTED AND THE SYSTEM CONTROLLER POWERED DOWN AT THE END OF THE PATIENT¿S EVENT HISTORY. MULTIPLE EVENTS WERE CAPTURED WHERE POWER WAS ELEVATED IN THE 10 TO 17 WATT RANGE THROUGHOUT THE PATIENT¿S EVENT HISTORY. THERE WERE ALSO MULTIPLE PULSE INDEX (PI) EVENTS, THE PI VARIED NOTABLY IN THE 1.8 TO 7.8 RANGE. SINCE THE SYSTEM CONTROLLER WAS EXCHANGED THE PATIENT HAD ADDITIONAL SYSTEM STOP AND HIGH POWER EVENTS. THE RETURNED SYSTEM CONTROLLER WAS FUNCTIONALLY TESTED AND FOUND TO OPERATE AS INTENDED DURING ANALYSIS. ATYPICAL PUMP STOPS WERE NOT OBSERVED OR REPRODUCED. THE PATIENT ULTIMATELY EXPIRED ON (B)(6) 2014 DUE TO HEART FAILURE. 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.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE VAD COORDINATOR PROVIDED A DATA LOG FILE FOR REVIEW AS THE CONTROLLER WAS SHOWING MULTIPLE POWER ELEVATIONS AND PULSATILITY INDEX (PI) EVENTS. THE PATIENT HAD A TRACHEOSTOMY AND WAS IN RENAL FAILURE REQUIRING CONTINUOUS BEDSIDE DIALYSIS, BUT WAS REPORTEDLY HEMODYNAMICALLY STABLE WITHOUT INOTROPIC MEDICATION AND WITH A STABLE LACTATE DEHYDROGENASE LEVEL. THE LOG FILE RECORDED ONE PUMP STOPPAGE AND MULTIPLE HIGH POWER HIGH FLOW EVENTS. THE SYSTEM CONTROLLER WAS EXCHANGED WITH NO CHANGE IN THE RECORDED VALUES. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367134 HEARTMATE II SYSTEM CONTROLLER DSQ: LVAD SYSTEM CONTROLLER DSQ THORATEC CORP. 106762 137950

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention