BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 8901335 · Received August 16, 2019

    Report

    Report Number
    2916596-2019-03722
    Event Type
    Death
    Date Received
    August 16, 2019
    Date of Event
    March 3, 2019
    Report Date
    May 11, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D4: CORRECTION. SECTION H4: ADDITIONAL INFORMATION. MANUFACTURER'S INVESTIGATION CONCLUSIONS: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LVAS, SERIAL NUMBER (B)(6), AND THE REPORTED EVENT COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE ACCOUNT SUBMITTED A LOG FILE FOR REVIEW. THE SYSTEM CONTROLLER EVENT LOG FILE CONTAINS DATA FROM (B)(6) 2019 AT 11:00:28 THROUGH (B)(6) 2019 AT 22:24:12. ON (B)(6) 2019 FROM 22:24:12 THROUGH 22:24:20, THE PUMP SPEED REDUCED TO 0RPM WITH LOW SPEED, LOW FLOW, COM A FAULT, COM B FAULT, AND PUMP STOP ADVISORIES BECAME ACTIVE. ON (B)(6) 2019 AT 22:26:06, THE LVAD OFF, CONTROLLER INTERNAL FAULT, AND LOW FLOW ALARMS WERE ACTIVE, AS WELL AS, COM A FAULT, COM B FAULT, PWR A BROKEN, PWR B BROKEN, OCP A OPEN, OCP B OPEN, BOOST OV, LOW PUMP CURRENT, LASTING UNTIL THE END OF THE LOG FILE. THE PATIENT EXPIRED ON (B)(6) 2019. THE HEARTMATE 3 LVAD, SERIAL NUMBER (B)(6), WAS NOT RETURNED FOR ANALYSIS. THE HM3 LVAS IFU CONTAINS IMPORTANT WARNINGS RELATED TO PUMP STOPS. THE ALARMS AND TROUBLESHOOTING SECTION PROVIDES INFORMATION REGARDING SYSTEM ALARMS AND STEPS TO RESOLVE THEM. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) (DOCUMENTS 163479, 169436, 166723, AND 169480) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR THE PERCUTANEOUS LEAD (DOCUMENTS 158526, 159773, 161864, AND 162244) WERE ALSO REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE IMPLANT KIT WAS SHIPPED ON 26FEB2016 VIA TRANSACTION NUMBER S172177. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S UPDATED INVESTIGATION CONCLUSIONS: ALTHOUGH AN LVAD OFF THE EVENT AND OTHER ALARMS WERE CONFIRMED VIA THE SUBMITTED LOG FILE, THE CAUSE COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. A DIRECT CORRELATION BETWEEN HEARTMATE 3 LVAS, SERIAL NUMBER (B)(6), AND THE REPORTED EVENT COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE ACCOUNT SUBMITTED A LOG FILE FOR REVIEW. REVIEW OF THE SUBMITTED CONTROLLER EVENT LOG FILE APPEARED TO CAPTURE THE DEVICE OPERATING AS INTENDED UNTIL A PUMP STOP OCCURRED IN ASSOCIATION WITH FUSE DAMAGE TO THE SYSTEM CONTROLLER. THE PUMP REMAINED OFF FOR THE REMAINDER OF THE LOG FILE. THE PATIENT EXPIRED ON (B)(6) 2019. THE HEARTMATE 3 LVAD, SERIAL NUMBER (B)(6), WAS NOT RETURNED FOR ANALYSIS. THE HM3 LVAS IFU CONTAINS IMPORTANT WARNINGS RELATED TO PUMP STOPS. THE ALARMS AND TROUBLESHOOTING SECTION PROVIDES INFORMATION REGARDING SYSTEM ALARMS AND STEPS TO RESOLVE THEM. THE HEARTMATE 3 INSTRUCTIONS FOR USE AND HEARTMATE 3 PATIENT HANDBOOK CAUTION THE USERS TO CALL THEIR HOSPITAL CONTACTS IF THEY THINK, FOR ANY REASON, ANY PORTION OF THEIR EQUIPMENT IS NOT FUNCTIONING AS USUAL, IS BROKEN, OR THEY ARE UNCOMFORTABLE WITH THE OPERATION OF THE EQUIPMENT. THESE DOCUMENTS CONTAIN INFORMATION ON ALL SYSTEM CONTROLLER ALARMS AND THE PROPER ACTIONS ASSOCIATED WITH THEM. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR THE PERCUTANEOUS LEAD WERE ALSO REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE IMPLANT KIT WAS SHIPPED ON (B)(6) 2016. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE ON (B)(6) 2016. IT WAS REPORTED THAT THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS NOT PROVIDED. LOG FILE REVIEW SHOWED TWO INSTANCES OF THE PUMP STOPPING. THE FIRST PUMP STOP LASTED FOR APPROXIMATELY 3 SECONDS BEFORE RESTARTING. APPROXIMATELY 2 MINUTED LATER, THE PUMP STOPPED AGAIN AND DID NOT RESTART. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695348 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524INT 6067843

    Patients

    Seq Age Sex Outcome Treatment
    1 Death