BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE

    MDR report key: 19088487 · Received April 11, 2024

    Report

    Report Number
    2916596-2024-01891
    Event Type
    Malfunction
    Date Received
    April 11, 2024
    Date of Event
    March 23, 2024
    Report Date
    September 18, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN ASSISTANT
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF A DRIVELINE POWER FAULT ALARM WAS CONFIRMED VIA ANALYSIS OF THE LOG FILES; HOWEVER, THE ALARM WAS NOT REPRODUCED DURING TESTING. THE REPORTED EVENT OF DUST/DIRT AROUND THE MODULAR CABLE CONNECTION WAS CONFIRMED VIA EVALUATION OF THE RETURNED MODULAR CABLE (LOT NUMBER: 9173975). THE SUBMITTED LOG FILE AND THE LOG FILE DOWNLOADED FROM THE RETURNED SYSTEM CONTROLLER (SERIAL NUMBER: (B)(6) CONTAINED DATA SPANNING 7 DAYS (B)(6) 2024 PER THE TIMESTAMP). A DRIVELINE POWER FAULT ALARM ACTIVATED AT 19:57:47 ON (B)(6) 2024 DUE TO THE CURRENT ONLINE A DROPPING BELOW THE THRESHOLD AMPERAGE. THE ALARM REMAINED ACTIVE UNTIL THE DRIVELINE WAS DISCONNECTED TO EXCHANGE THE SYSTEM CONTROLLER AT 22:40:10 ON (B)(6) 2024. THE PUMP MAINTAINED A SPEED WITHIN THE EXPECTED RANGE THROUGHOUT THE LOG FILE WHILE THE DRIVELINE WAS CONNECTED. THE RETURNED MODULAR CABLE WAS VISUALLY INSPECTED AND THERE WAS DUST/DIRT OBSERVED AROUND THE EDGE OF THE INLINE CONNECTOR NUT. THE DUST/DIRT DID NOT PREVENT THE MODULAR CABLE FROM MAKING A COMPLETE AND SECURE CONNECTION TO A LABORATORY PUMP CABLE. THE MODULAR CABLE WAS FUNCTIONALLY TESTED WITH THE RETURNED SYSTEM CONTROLLER ON A MOCK CIRCULATORY LOOP AND WAS FOUND TO FUNCTION AS INTENDED WITHOUT ANY ISSUES OR ATYPICAL ALARMS PRODUCED. THE INTEGRITY OF THE INTERNAL WIRES OF THE RETURNED MODULAR CABLE WAS TESTED AND THE MODULAR CABLE PASSED WITHOUT ISSUE. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. HEARTMATE 3 PATIENT HANDBOOK (REV. D), UNDER SECTION 5 ¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE 3 INSTRUCTIONS FOR USE (IFU) (REV. C), UNDER SECTION 7 ¿ALARMS AND TROUBLESHOOTING¿ COVER ALL ALARMS (VISUAL AND AUDIBLE), INCLUDING THE DRIVELINE POWER FAULT, POWER CABLE DISCONNECT, NO EXTERNAL POWER, AND LOW VOLTAGE HAZARD ALARM CONDITIONS, AND THE ACTIONS TO TAKE IF THE ALARMS CANNOT BE RESOLVED. HEARTMATE 3 PATIENT HANDBOOK (REV. D) SECTION 6 "CARING FOR THE EQUIPMENT" AND HEARTMATE 3 INSTRUCTIONS FOR USE (IFU) (REV. C) SECTION 8 "EQUIPMENT STORAGE AND CARE" DESCRIBE HOW TO CARE FOR AND CLEAN ALL EQUIPMENT. HEARTMATE 3 PATIENT HANDBOOK (REV. D) SECTION 10 AND HEARTMATE 3 INSTRUCTIONS FOR USE (IFU) (REV. C) SECTION F, BOTH ENTITLED ¿SAFETY CHECKLISTS¿, PROVIDE CHECKLISTS TO ASSIST THE PATIENT IN PERFORMING ROUTINE MAINTENANCE OF THE HEARTMATE 3 LVAD. THIS SECTION ALSO INFORMS THE USER TO REPLACE ANY EQUIPMENT OR SYSTEM COMPONENT THAT APPEARS DAMAGED OR WORN. HEARTMATE 3 PATIENT HANDBOOK (REV. D) 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. DEVICE HISTORY RECORDS WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    D1: BRAND NAME: CORRECTED. D4: CATALOG NUMBER AND UDI: CORRECTED. MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF A DRIVELINE POWER FAULT ALARM WAS CONFIRMED VIA ANALYSIS OF THE LOG FILES; HOWEVER, THE ALARM WAS NOT REPRODUCED DURING TESTING. THE REPORTED EVENT OF DUST/DIRT AROUND THE MODULAR CABLE CONNECTION WAS CONFIRMED VIA EVALUATION OF THE RETURNED MODULAR CABLE (LOT NUMBER: 9173975). THE SUBMITTED LOG FILE AND THE LOG FILE DOWNLOADED FROM THE RETURNED SYSTEM CONTROLLER (SERIAL NUMBER: (B)(6) CONTAINED DATA SPANNING 7 DAYS ( ON (B)(6) 2024 PER THE TIMESTAMP). A DRIVELINE POWER FAULT ALARM ACTIVATED AT 19:57:47 ON (B)(6) 2024 DUE TO THE CURRENT ON LINE A DROPPING BELOW THE THRESHOLD AMPERAGE. THE ALARM REMAINED ACTIVE UNTIL THE DRIVELINE WAS DISCONNECTED TO EXCHANGE THE SYSTEM CONTROLLER AT 22:40:10 ON (B)(6) 2024. THE PUMP MAINTAINED A SPEED WITHIN THE EXPECTED RANGE THROUGHOUT THE LOG FILE WHILE THE DRIVELINE WAS CONNECTED. THE RETURNED MODULAR CABLE WAS VISUALLY INSPECTED AND THERE WAS DUST/DIRT OBSERVED AROUND THE EDGE OF THE INLINE CONNECTOR NUT. THE DUST/DIRT DID NOT PREVENT THE MODULAR CABLE FROM MAKING A COMPLETE AND SECURE CONNECTION TO A LABORATORY PUMP CABLE. THE MODULAR CABLE WAS FUNCTIONALLY TESTED WITH THE RETURNED SYSTEM CONTROLLER ON A MOCK CIRCULATORY LOOP AND WAS FOUND TO FUNCTION AS INTENDED WITHOUT ANY ISSUES OR ATYPICAL ALARMS PRODUCED. THE INTEGRITY OF THE INTERNAL WIRES OF THE RETURNED MODULAR CABLE WAS TESTED AND THE MODULAR CABLE PASSED WITHOUT ISSUE. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. DEVICE HISTORY RECORDS WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. HEARTMATE 3 PATIENT HANDBOOK, UNDER SECTION 5 ¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE 3 INSTRUCTIONS FOR USE (IFU) (DOC #100169835, REV. C), UNDER SECTION 7 ¿ALARMS AND TROUBLESHOOTING¿ COVER ALL ALARMS (VISUAL AND AUDIBLE), INCLUDING THE DRIVELINE POWER FAULT, POWER CABLE DISCONNECT, NO EXTERNAL POWER, AND LOW VOLTAGE HAZARD ALARM CONDITIONS, AND THE ACTIONS TO TAKE IF THE ALARMS CANNOT BE RESOLVED. HEARTMATE 3 PATIENT HANDBOOK SECTION 6 "CARING FOR THE EQUIPMENT" AND HEARTMATE 3 INSTRUCTIONS FOR USE (IFU) SECTION 8 "EQUIPMENT STORAGE AND CARE" DESCRIBE HOW TO CARE FOR AND CLEAN ALL EQUIPMENT. HEARTMATE 3 PATIENT HANDBOOK SECTION 10 AND HEARTMATE 3 INSTRUCTIONS FOR USE (IFU) SECTION F, BOTH ENTITLED ¿SAFETY CHECKLISTS¿, PROVIDE CHECKLISTS TO ASSIST THE PATIENT IN PERFORMING ROUTINE MAINTENANCE OF THE HEARTMATE 3 LVAD. THIS SECTION ALSO INFORMS THE USER TO REPLACE ANY EQUIPMENT OR SYSTEM COMPONENT THAT APPEARS DAMAGED OR WORN. HEARTMATE 3 PATIENT HANDBOOK 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 REPORTED A DRIVELINE POWER FAULT IN THE EVENING. THE PATIENT ARRIVED AT THE EMERGENCY DEPARTMENT. THE PATIENT'S SYSTEM CONTROLLER AND MODULAR CABLE WERE EXCHANGED WITHOUT ISSUE. THE PATIENT STAYED OVERNIGHT FOR OBSERVATION. NO APPARENT DAMAGE TO THE CONTROLLER OR DRIVELINE WAS NOTED. ONCE DETACHED, THE DRIVELINE CONNECTIONS WERE EXAMINED AND SOME DUST/DIRT WAS NOTED AROUND THE MODULAR CABLE CONNECTION; HOWEVER, NO OTHER ISSUES WERE NOTED. A REVIEW OF THE LOG FILE CONFIRMED DRIVELINE POWER A FAULTS ON (B)(6) 2024. THERE WAS NO INTERRUPTION IN PUMP SUPPORT DURING THESE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691295 THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525US 9173975 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male