BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 SYSTEM CONTROLLER

    MDR report key: 17492376 · Received August 9, 2023

    Report

    Report Number
    2916596-2023-05924
    Event Type
    Malfunction
    Date Received
    August 9, 2023
    Date of Event
    August 4, 2023
    Report Date
    August 24, 2023
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013235
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: INCIDENTAL FINDINGS: BROKEN STRAIN RELIEFS WERE OBSERVED ON BOTH POWER CABLES, FLUID INGRESS ON BOTH POWER CABLES AND INSIDE THE CONTROLLER. THE REPORTED EVENT OF DRIVELINE POWER FAULT ALARMS WAS CONFIRMED VIA ANALYSIS OF THE LOG FILES; HOWEVER, THE REPORTED ALARMS DID NOT REPRODUCE DURING TESTING OF THE RETURNED OF THE HEARTMATE 3 SYSTEM CONTROLLER (SERIAL NUMBER: (B)(6)). THE CONTROLLER EVENT LOG FILES CONTAINED APPROXIMATELY 1.5 HOURS OF DATA COMBINED (04AUG223 FROM 14:12:52 TO 15:29:14 PER THE TIMESTAMP). A DRIVELINE POWER FAULT ALARM ASSOCIATED WITH A POWER A BROKEN FAULT WAS OBSERVED THROUGHOUT THE LOG FILE DUE TO THE CURRENT SENSE ON LINE A DROPPING BELOW THE THRESHOLD AMPERAGE. THE DRIVELINE WAS DISCONNECTED ON 04AUG2023 AT 15:43:20 TO EXCHANGE THE CONTROLLER. THE INITIAL CONDITIONS THAT CAUSED THE DRIVELINE POWER FAULT ALARM TO ACTIVATE WERE NOT CAPTURED IN THE LOG FILE AND THE ALARM WAS NOT OBSERVED TO RESOLVE WHILE THE CONTROLLER WAS IN USE. THERE WERE NO OTHER NOTABLE ALARMS THROUGHOUT THE LOG FILES. THE PUMP MAINTAINED A SPEED ABOVE THE LOW SPEED LIMIT WHILE THE DRIVELINE WAS CONNECTED. THE RETURNED SYSTEM CONTROLLER PASSED FUNCTIONAL TESTING AND SUCCESSFULLY OPERATED IN A MOCK CIRCULATORY LOOP FOR AN EXTENDED PERIOD OF TIME WITHOUT ANY ISSUES OR ATYPICAL ALARMS PRODUCED. THE SYSTEM CONTROLLER WAS ALSO TESTED WITH THE RETURNED MODULAR CABLE (LOT NUMBER: 8140086) AND NO ISSUES WERE OBSERVED. IT WAS REPORTED THAT NO FURTHER ALARMS HAVE BEEN OBSERVED AFTER EXCHANGING THE CONTROLLER AND THE MODULAR CABLE. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE RECORDS REVEALED THAT THE HEARTMATE 3 SYSTEM CONTROLLER, SERIAL NUMBER (B)(6), WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. HEARTMATE 3 INSTRUCTIONS FOR USE SECTION 7, ENTITLED ¿ALARMS AND TROUBLESHOOTING¿, AND HEARTMATE 3 PATIENT HANDBOOK SECTION 5, ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ COVERS ALL ALARMS (VISUAL AND AUDIBLE), INCLUDING THE DRIVELINE POWER FAULT AND BACKUP BATTERY FAULT ALARM CONDITIONS, AND THE ACTIONS TO TAKE IF THE ALARM CANNOT BE RESOLVED. THE SUBSECTION ENTITLED ¿WHAT NOT TO DO: DRIVELINE AND CABLES¿ DESCRIBES CHECKING THE DRIVELINE CABLE FOR TWISTING, KINKING, OR BENDING WHICH COULD CAUSE DAMAGE TO THE WIRES INSIDE, EVEN IF EXTERNAL DAMAGE IS NOT VISIBLE. DAMAGE TO THE DRIVELINE OR CABLES COULD CAUSE THE LEFT VENTRICULAR ASSIST DEVICE TO STOP. HEARTMATE 3 INSTRUCTIONS FOR USE SECTION 8, ENTITLED ¿EQUIPMENT STORAGE AND CARE¿, AND HEARTMATE 3 PATIENT HANDBOOK SECTION 6, ENTITLED ¿CARING FOR EQUIPMENT¿, EXPLAIN HOW TO PROPERLY CARE FOR THE MODULAR CABLE, AND THE SYSTEM CONTROLLER. HEARTMATE 3 PATIENT HANDBOOK SECTION 10, ENTITLED ¿SAFETY CHECKLISTS¿, AND HEARTMATE 3 INSTRUCTIONS FOR USE SECTION F, ENTITLED ¿SAFETY CHECKLIST¿, PROVIDE CHECKLISTS TO ASSIST THE PATIENT IN PERFORMING ROUTINE MAINTENANCE OF HEARTMATE 3 LVAD, INCLUDING INSPECTING THE SYSTEM CONTROLLER, THE SYSTEM CONTROLLER POWER CABLES, AND THE MODULAR CABLE FOR DAMAGE. THE HEARTMATE 3 PATIENT HANDBOOK CAUTIONS THE USER 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.

    Additional Manufacturer Narrative · 0

    NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REPORT NUMBER: 2916596-2023-05923. IT WAS REPORTED THAT THE PATIENT HAD A DRIVELINE POWER FAULT. THEIR SYSTEM CONTROLLER AND MODULAR CABLE WERE EXCHANGED. THE ALARMS DID NOT RETURN FOLLOWING THE EQUIPMENT EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2014174 HEARTMATE 3 SYSTEM CONTROLLER VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106531US 8077270 00813024013235

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male