BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER

    MDR report key: 18426505 · Received January 2, 2024

    Report

    Report Number
    2916596-2023-08898
    Event Type
    Malfunction
    Date Received
    January 2, 2024
    Date of Event
    December 15, 2023
    Report Date
    June 3, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013235
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 COMPLETE.

    Additional Manufacturer Narrative · 0

    SECTION B2: CORRECTED. SECTION D1: CORRECTED. SECTION D4: CORRECTED CATALOG NUMBER AND UDI. MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF DRIVELINE DISCONNECT AND PUMP STOP ALARMS CAN BE CONFIRMED BASED ON THE INFORMATION RECORDED IN THE PROVIDED LOG FILES. THE DATA CONTAINED IN THE EVENT LOG FILE (CS-190377 MCS-190377_6_CC1_C3E) RETRIEVED FROM THE SYSTEM CONTROLLER, SERIAL NUMBER (B)(6) REVEALED THAT THE SYSTEM WAS OPERATING WITH NO ATYPICAL ALARMS FROM 14DEC2023 TO 15DEC2023 WHEN ON 15DEC2023 AT 15:01 A BACKUP BATTERY FAULT ALARM ASSOCIATED WITH AN EBB LOAD TEST FAIL (ERROR CODE F36) BECAME ACTIVE. THE SYSTEM CONTINUED TO OPERATE WITH AN ACTIVE BACKUP BATTERY FAULT ALARM UNTIL 15:07 WHEN THE DRIVELINE WAS DISCONNECTED. THE DATA CAPTURED AT 20:06 REVEALED THAT THE DRIVELINE WAS RECONNECTED AND THE SYSTEM INITIATED OPERATION AT THE SET SPEED OF 5600 RPM WITH AN ACTIVE BACKUP BATTERY FAULT ALARM. IN ADDITION TO THE BACKUP BATTERY FAULT ALARM, THERE WAS A LOW FLOW ALARM. AFTER THE DRIVELINE WAS RECONNECTED, THE FLOW INCREASED TO 2.9-3.5 LPM AND THEN DECREASED TO 0 LPM. THE DATA CAPTURED BETWEEN 20:23 AND 20:48 REVEALED THAT THE DRIVELINE WAS DISCONNECTED AND RECONNECTED FEW TIMES. THE DATA CAPTURED AT 20:48 INDICATED THAT THE DRIVELINE WAS DISCONNECTED AND THE EXTERNAL POWER (14V BATTERIES) WAS ALSO DISCONNECTED. THE DRIVELINE WAS RECONNECTED; HOWEVER, DID PUMP DID NOT RESTART DUE TO THE LACK OF EXTERNAL POWER. THE REMAINING DATA REVEALED THAT THE SYSTEM CONTROLLER WAS CONNECTED TO AN EXTERNAL POWER (14V BATTERIES) ON 16DEC2023 AT 00:02 AND WITH THE DRIVELINE BEING CONNECTED, THE SYSTEM INITIATED OPERATION AT THE SET SPEED; HOWEVER, THE FLOW REMAINED AT 0 RPM AND THE DRIVELINE WAS DISCONNECTED AT 00:05 AND THE POWER WAS REMOVED FROM THE SYSTEM CONTROLLER. THE PERIODIC LOG FILE (CS-190377 MCS-190377_2_CC1_C3P) CONTAINED EVENTS FROM 10AUG2023 TO 15DEC2023. THE RECORDED DATA DID NOT ADD ANY NEW INFORMATION REGARDING THE REPORTED EVENT. THE SYSTEM CONTROLLER, SERIAL NUMBER (B)(6), WAS NOT RETURNED FOR TESTING. PER THE PROVIDED ADDITIONAL INFORMATION, NO PRODUCT WILL BE RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE BACKUP BATTER FAULT ALARM CAPTURED IN THE LOG FILE COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. AN UPDATE TO THE BACKUP BATTERY CONNECTOR WAS MADE TO REDUCE THE OCCURRENCE OF BACKUP BATTERY FAULTS DUE TO LOAD TEST FAILURES AS PART OF A CORRECTIVE AND PREVENTIVE ACTION. PER THE DEVICE HISTORY RECORDS REVIEW THIS SYSTEM CONTROLLER WAS MANUFACTURED PRIOR TO THE IMPLEMENTATION OF THE CORRECTIVE ACTION. THE DEVICE HISTORY RECORDS WERE REVIEWED, AND THE RECORDS REVEALED THE CONTROLLER WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. HEARTMATE 3 PATIENT HANDBOOK, UNDER SECTION 5 ¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE 3 INSTRUCTIONS FOR USE REV C, UNDER SECTION 7 ¿ALARMS AND TROUBLESHOOTING¿ EXPLAIN ALL ALARMS AND THE PROPER ACTIONS TO TAKE IF THE ALARMS CANNOT BE RESOLVED. HEARTMATE 3 PATIENT HANDBOOK CAUTIONS THE USERS TO ¿CALL YOUR HOSPITAL CONTACT IF YOU THINK THAT, FOR ANY REASON, ANY PORTION OF YOUR EQUIPMENT IS NOT FUNCTIONING AS USUAL, IS BROKEN, OR YOU ARE UNCOMFORTABLE WITH THE OPERATION OF THE EQUIPMENT. YOUR HOSPITAL CONTACT CAN CHECK THE EQUIPMENT AND ORDER REPLACEMENTS, IF NEEDED. DO NOT TRY TO REPAIR ANYTHING YOURSELF.¿ ALSO, CAUTION USERS ¿DO NOT ATTEMPT TO CHANGE YOUR SYSTEM CONTROLLER WITHOUT HAVING A TRAINED, COMPETENT CAREGIVER AT YOUR SIDE TO ASSIST. FOLLOW ALL ALARM INSTRUCTIONS, INCLUDING CALLING THE HOSPITAL.¿ HEARTMATE 3 INSTRUCTIONS FOR USE REV C, UNDER SECTION 2 SYSTEM OPERATION, COVERS ¿REPLACING THE CURRENT SYSTEM CONTROLLER¿. THE DOCUMENT CONTAINS A WARNING REGARDING THE IMPORTANCE OF THE EXTERNAL POWER SOURCE DURING A CONTROLLER EXCHANGE: THE 11 VOLT LITHIUM-ION BACK UP BATTERY INSIDE THE SYSTEM CONTROLLER WILL NOT BY ITSELF START A HEARTMATE 3 LVAD IF BOTH OF THE SYSTEM CONTROLLER'S POWER CABLES ARE DISCONNECTED FROM A POWER SOURCE. ALWAYS ENSURE THAT THE POWER CABLES ARE CONNECTED TO A POWER SOURCE TO ENSURE THAT THE HEARTMATE 3 PUMP WILL RESTART DURING A SYSTEM CONTROLLER EXCHANGE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT EVENT LOG FILES WERE URGENTLY SUBMITTED FOR THE PATIENT WHO WAS FOUND DOWN AT HOME WITH DRIVELINE DISCONNECT ALARMS AND PUMP STOP ALARMS ON (B)(6) 2023. THE EVENT LOG FILES CAPTURED MULTIPLE DRIVELINE DISCONNECT EVENTS BEGINNING AT 3:07 PM ON (B)(6) 2023. THE EVENT LOG FILES ALSO CAPTURED BACKUP BATTERY (EBB) ALARMS BEGINNING AT 3:01 PM ON (B)(6) 2023. IT APPEARED THAT THE PATIENT SWAPPED TO THE BACKUP SYSTEM CONTROLLER AFTER THE EBB FAULT ALARMS. IT ALSO APPEARED THAT THE PATIENT CONNECTED BACK TO THE PRIMARY SYSTEM CONTROLLER A FEW MORE TIMES THAT DAY. THE EVENT LOG FILES FOR THE BACKUP SYSTEM CONTROLLER CAPTURED NO DATA. THE DRIVELINE WAS DISCONNECTED AND RECONNECTED IN THE EMERGENCY ROOM. RELATED MANUFACTURER REFERENCE NUMBER: 2916596-2023-08896 (HEARTMATE 3 PUMP (B)(4). RELATED MANUFACTURER REFERENCE NUMBER: 2916596-2023-08899 (SYSTEM CONTROLLER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1451179 THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106531US 6550972 00813024013235

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Required Intervention