BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 11116511 · Received January 5, 2021

    Report

    Report Number
    2916596-2021-00012
    Event Type
    Injury
    Date Received
    January 5, 2021
    Date of Event
    September 2, 2020
    Report Date
    January 22, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORT OF LOW FLOW ALARMS WAS CONFIRMED VIA THE SUBMITTED LOG FILE. ACCORDING TO THE ACCOUNT, THE LOW FLOWS WERE DUE TO ARRHYTHMIA. A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), AND THE REPORTED EVENTS 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) 2020 AT 6:59:20 THROUGH (B)(6) 2020 AT 19:39:00. LOW FLOW EVENTS WERE CAPTURED THROUGHOUT THE LOG FILE FROM (B)(6) 2020 AT 12:06:14 THROUGH 13:11:16. PER DESIGN, WHEN THE FLOW VALUE IS CALCULATED AT LESS THAN 2.5 LPM, A LOW FLOW STATUS IS POSTED TO THE LOG FILE. A 10-SECOND DELAY IS IMPOSED BETWEEN THE DETECTION OF THE LOW FLOW STATUS AND THE ACTIVATION OF THE ASSOCIATED AUDIO AND VISUAL INDICATORS ON THE SYSTEM CONTROLLER. SOME OF THE EVENTS LASTED OVER 10 SECONDS, AND LOW FLOW ALARMS WERE FLAGGED. THE PUMP APPEARED TO FUNCTION AS INTENDED. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LVAS, SERIAL NUMBER (B)(6) 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 28MAY2020. THE HEARTMATE 3 LVAS INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. THE SECTION ENTITLED ¿SYSTEM MONITOR¿ EXPLAINS THAT THE LOW FLOW HAZARD ALARM IS TRIGGERED WHEN PUMP FLOW IS LESS THAN 2.5 LPM, THE PUMP HAS STOPPED, THE PUMP IS NOT OPERATING PROPERLY, OR THE DRIVELINE IS DISCONNECTED FROM THE SYSTEM CONTROLLER. CHANGES IN PATIENT CONDITIONS CAN RESULT IN LOW FLOW, SUCH AS HYPERTENSION. THE SECTION ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ EXPLAINS ALL SYSTEM ALARMS AND THE RECOMMENDED ACTIONS ASSOCIATED WITH THEM. THIS DOCUMENT ALSO EXPLAINS THAT PI EVENTS ARE ASSUMED BY THE SYSTEM DURING CASES WHEN THERE ARE SUDDEN AND SUBSTANTIAL CHANGES IN THE PULSATILITY INDEX. THESE EVENTS ARE ALSO REFERRED TO AS PI EVENTS, AND MAY BE INITIATED FOR REASONS OTHER THAN TRUE PI EVENTS. SOME REASONS INCLUDE SUDDEN CHANGES IN A PATIENT¿S VOLUME STATUS, ARRHYTHMIAS, SUDDEN CHANGES IN POWER, AND SUDDEN CHANGES IN PUMP SPEED. IF THE SYSTEM DETECTS A PI EVENT, THE PUMP SPEED AUTOMATICALLY DROPS TO THE LOW SPEED LIMIT AND SLOWLY RAMPS BACK UP AT A RATE OF 100 RPM PER SECOND TO THE FIXED SPEED SETPOINT. THIS DROP IN SPEED IS ACCOMPANIED BY A REDUCED PUMP FLOW. THERE ARE NO AUDIBLE ALARMS WITH A PI EVENT. THE HEARTMATE 3 LVAS PATIENT HANDBOOK IS ALSO AVAILABLE. THE SECTION ENTITLED "ALARMS AND TROUBLESHOOTING" OUTLINES ALL SYSTEM CONTROLLER ALARMS AS WELL AS HOW TO RESPOND TO EACH ALARM CONDITION. THIS DOCUMENT PATIENT THE USER THAT IN THE EVENT OF A LOW FLOW HAZARD ALARM, CALL YOUR HOSPITAL CONTACT IMMEDIATELY FOR DIAGNOSIS AND INSTRUCTIONS. 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

    IT WAS REPORTED THAT THE PATIENT PASSED OUT AT HOME AND A LOG FILE REVIEW NOTED MULTIPLE LOW FLOW EVENTS. THE PATIENT¿S LOW FLOW ALARMS WERE DUE TO AN ARRHYTHMIA. THE SUBJECT BLACKED OUT AND GOT ADMITTED TO THE HOSPITAL. THE PATIENT RECEIVED A CARDIOVERSION ON (B)(6) 2020 AND A STELLATE GANGLION BLOCK ON (B)(6) 2020. THE PATIENT WAS DISCHARGED (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14611 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524US 7455478 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R