BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 14574975 · Received June 2, 2022

    Report

    Report Number
    2916596-2022-11427
    Event Type
    Malfunction
    Date Received
    June 2, 2022
    Date of Event
    May 31, 2022
    Report Date
    July 29, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: REVIEW OF THE SUBMITTED LOG FILES CONFIRMED THE REPORTED EVENT OF DRIVELINE POWER FAULT ALARMS; HOWEVER, A SPECIFIC CAUSE FOR THE ALARMS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. EVALUATION OF THE RETURNED MODULAR CABLE UNDER PI-2022-0082463-03 DID NOT REVEAL ANY ISSUES THAT WOULD HAVE CONTRIBUTED TO REPORTED EVENT. THE MODULAR CABLE WAS EXCHANGED, AND NO FURTHER ALARMS WERE REPORTED. THE CONTROLLER EVENT LOG FILES CONTAINED DATA FROM (B)(6) 2022 THROUGH (B)(6) 2022. TWO DRIVELINE POWER FAULT ALARMS WERE CAPTURED ON (B)(6) 2022 AND (B)(6) 2022. DESPITE THE ALARMS, THE PUMP APPEARED TO FUNCTION AS INTENDED AT THE SET SPEED. NO OTHER NOTABLE EVENTS WERE CAPTURED. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6) , WITH NO FURTHER ISSUES REPORTED AT THIS TIME. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATION. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), REV. G, AND THE HEARTMATE 3 LVAS PATIENT HANDBOOK, REV. G, ARE CURRENTLY AVAILABLE. SECTION 6 OF THE IFU, ¿PATIENT CARE AND MANAGEMENT¿, INSTRUCTS THE USER TO CHECK THE DRIVELINE DAILY FOR SIGNS OF DAMAGE, SUCH AS CUTS, HOLES, OR TEARS AND URGES PATIENTS TO INFORM THEIR HOSPITAL CONTACT IMMEDIATELY IF THEY FIND SIGNS OF DRIVELINE DAMAGE. SECTION 7 OF THE IFU, ¿ALARMS AND TROUBLESHOOTING¿, PROVIDES INSTRUCTION REGARDING HOW TO CARE FOR THE DRIVELINE IN A SUB-SECTION ENTITLED "WHAT NOT TO DO: DRIVELINE AND CABLES." SECTION 7 ALSO OUTLINES ALL SYSTEM CONTROLLER ALARMS, INCLUDING THE DRIVELINE POWER FAULT, AS WELL AS HOW TO RESPOND TO EACH ALARM CONDITION. SECTION 8, ¿EQUIPMENT STORAGE AND CARE¿, STATES: "AS NEEDED, CLEAN EXTERIOR SURFACES OF THE DRIVELINE CABLES WITH A DAMP, LINT-FREE CLOTH. IF MORE AGGRESSIVE CLEANING IS NEEDED, USE WARM WATER AND MILD DISH SOAP." SECTION 1 OF THE IFU, ¿INTRODUCTION¿, ADDRESSES ALL PUMP PARAMETERS, INCLUDING PUMP FLOW. SECTION 4, ¿SYSTEM MONITOR¿, DESCRIBES THE PUMP FLOW DISPLAY AND THE HAZARD ALARMS. THE IFU STATES THAT PER DESIGN, WHEN THE ESTIMATED FLOW VALUE IS CALCULATED AT LESS THAN 2.5 LPM, A LOW FLOW STATUS IS POSTED TO THE LOG FILE. IF THE FLOW REMAINS BELOW 2.5 LPM FOR 10 SECONDS, A LOW FLOW HAZARD ALARM IS TRIGGERED. THIS SECTION ALSO EXPLAINS THAT CHANGES IN PATIENT CONDITION CAN RESULT IN LOW FLOW. SECTION 4 OF THE PATIENT HANDBOOK, ¿LIVING WITH THE HEARTMATE III¿, CONTAINS INFORMATION REGARDING HOW TO CLEAN AND CARE FOR THE DRIVELINE. THIS SECTION INSTRUCTS THE USER TO CHECK THE DRIVELINE DAILY FOR SIGNS OF DAMAGE AND TO CALL YOUR HOSPITAL CONTACT RIGHT AWAY IF THE DRIVELINE IS DAMAGED. THIS SECTION ALSO INSTRUCTS THE USER TO ¿KEEP YOUR DRIVELINE CLEAN. WIPE OFF ANY DIRT OR GRIME. IF THE DRIVELINE GETS DIRTY, USE A TOWEL WITH MILD DISH SOAP AND WARM WATER TO GENTLY CLEAN IT¿. SECTION 5, ¿ALARMS AND TROUBLESHOOTING¿, CAUTIONS THE USER NOT TO TWIST, KINK, OR SHARPLY BEND THE DRIVELINE. SECTION 5 OF THE PATIENT HANDBOOK, ¿ALARMS AND TROUBLESHOOTING¿, CONTAINS A SUBSECTION ENTITLED ¿WHAT NOT TO DO: DRIVELINE AND CABLES¿ WHICH CONTAINS INFORMATION REGARDING HOW TO CARE FOR THE DRIVELINE. SECTION 5 ALSO OUTLINES ALL SYSTEM CONTROLLER ALARMS, INCLUDING THE DRIVELINE POWER FAULT, AS WELL AS HOW TO RESPOND TO EACH ALARM CONDITION. THE PATIENT HANDBOOK ALSO CAUTIONS 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. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT CALLED THE HOSPITAL DUE TO A DRIVELINE POWER FAULT WHICH OCCURRED ON 31MAY2022 DURING WORKING IN THE GARDEN AND COOKING, ACCOMPANIED BY A YELLOW WRENCH AND INTERMITTENT BEEP. THE PUMP RAN AS EXPECTED THE WHOLE TIME AND THE PATIENT WAS STABLE. THE CONTROLLER WAS EXCHANGED AND THE ISSUE RESOLVED. THE LOG FILES SHOWED A POWER A BROKEN FLAG ON 13:02 WITH A SUDDEN DECREASE IN DRIVELINE CURRENT ON LINE A TO MAX 0.5% AND AN INCREASE ON LINE B UP TO 99% AND THE DRIVELINE POWER FAULT POPPED UP. THE DRIVELINE CURRENT ON BOTH LINES RECOVERED ON 13:13. THE CONTROLLER WAS EXCHANGED AT 13:18. A SUDDEN KINKING OR CLAMPING OF THE DRIVELINE WAS SUSPECTED. RELATED MANUFACTURER REFERENCE REPORT: 2916596-2022-11429.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197805 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524INT 5997887

    Patients

    Seq Age Sex Outcome Treatment
    1 Female