THORATEC® HEARTMATE 3® LVAS IMPLANT KIT
Report
- Report Number
- 2916596-2022-01240
- Event Type
- Death
- Date Received
- March 14, 2022
- Date of Event
- February 20, 2022
- Report Date
- December 20, 2024
- 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
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.
MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), AND THE REPORTED PATIENT OUTCOME COULD NOT BE CONCLUSIVELY DETERMINED. ADDITIONALLY, REVIEW OF THE SUBMITTED LOG FILES CONFIRMED PUMP STOPS ASSOCIATED WITH DRIVELINE DISCONNECT EVENTS. A SPECIFIC CAUSE FOR THE DRIVELINE DISCONNECTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) WITH DRIVELINE COMMUNICATION FAULT AND PUMP OFF ALARMS. IT WAS NOTED THAT THE PATIENT WAS FOUND UNRESPONSIVE AND WAS BROUGHT TO THE ER BY EMERGENCY RESPONDERS. ON (B)(6) 2022 IT WAS REPORTED THAT THE PATIENT EXPIRED. THE CONTROLLER EVENT LOG FILE CONTAINED DATA FROM (B)(6) 2022 THROUGH (B)(6) 2022, PER THE TIMESTAMPS. ON (B)(6) 2022 A DRIVELINE DISCONNECT EVENT WAS CAPTURED, CAUSING THE PUMP TO STOP. ALTHOUGH NO DRIVELINE COMMUNICATION FAULT ALARMS WERE IDENTIFIED IN THE LOG FILE, FOLLOWING THIS DRIVELINE DISCONNECT, A CONTROLLER INTERNAL FAULT ALARM BECAME ACTIVE WHICH WAS ASSOCIATED WITH FAULTS INDICATING THAT A FUSE IN THE SYSTEM CONTROLLER HAD OPENED (REFERENCE THE SYSTEM CONTROLLER INVESTIGATION). FOLLOWING THIS EVENT, THE DRIVELINE WAS RECONNECTED, BUT WAS LATER DISCONNECTED AGAIN. THE DRIVELINE WAS DISCONNECTED FOR THE REMAINING DURATION OF THE FILE. NO OTHER NOTABLE EVENTS WERE CAPTURED. THE PUMP APPEARED TO FUNCTION AS INTENDED AT THE SET SPEED WHILE THE DRIVELINE WAS CONNECTED. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER REGARDING THE EVENT; HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), REV. C, AND THE HEARTMATE 3 LVAS PATIENT HANDBOOK, REV. D, ARE CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM, INCLUDING DEATH. THIS SECTION ALSO ADDRESSES ALL PUMP PARAMETERS, INCLUDING PUMP FLOW. SECTION 2 OF THE IFU, "SYSTEM OPERATIONS" (UNDER "SYSTEM CONTROLLER WARNINGS AND CAUTIONS"), STATES "CHECK THE SYSTEM CONTROLLER DRIVELINE CONNECTOR TO CONFIRM THAT THE DRIVELINE IS SECURELY INSERTED IN THE SOCKET. IF THE DRIVELINE DISCONNECTS FROM THE SYSTEM CONTROLLER, THE PUMP STOPS. IF THE DRIVELINE DISCONNECTS FROM THE SYSTEM CONTROLLER, PROMPTLY RECONNECT IT TO RESUME PUMP OPERATION." ADDITIONALLY, SECTION 2 OF THE IFU, UNDER "CONNECTING THE DRIVELINE TO THE SYSTEM CONTROLLER", PROVIDES INSTRUCTIONS ON CONNECTING/DISCONNECTING THE DRIVELINE TO/FROM THE SYSTEM CONTROLLER AND MAKING SURE THAT IT IS FULLY AND PROPERLY INSERTED INTO THE SYSTEM CONTROLLER SOCKET. SECTION 4 OF THE IFU, ¿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 2 OF THE PATIENT HANDBOOK, ¿HOW YOUR HEART PUMP WORKS¿, ALSO ADVISES THE USER TO ¿CHECK THE SYSTEM CONTROLLER DRIVELINE CONNECTOR OFTEN TO CONFIRM THAT THE DRIVELINE IS SECURELY INSERTED IN THE SOCKET. IF THE DRIVELINE DISCONNECTS FROM THE SYSTEM CONTROLLER, THE PUMP WILL STOP. IF THE DRIVELINE DISCONNECTS FROM THE SYSTEM CONTROLLER, PROMPTLY RECONNECT IT TO RESUME PUMP OPERATION¿. THE PATIENT HANDBOOK ALSO EXPLAINS THAT THE PUMP CANNOT RUN WITHOUT POWER. SECTION 7 OF THE IFU, "ALARMS AND TROUBLESHOOTING", AND SECTION 5 OF THE PATIENT HANDBOOK, "ALARMS AND TROUBLESHOOTING", ADDRESS ALL SYSTEM ALARM CONDITIONS AS WELL AS THE APPROPRIATE ACTIONS ASSOCIATED WITH EACH CONDITION. FURTHERMORE, SECTION 8 OF THE PATIENT HANDBOOK, ¿HANDLING EMERGENCIES¿, ALSO PROVIDES EXAMPLES OF EMERGENCIES AND THE PROPER ACTIONS TO TAKE IN THE EVENT AN EMERGENCY OCCURS. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATION. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.
MANUFACTURER'S INVESTIGATION CONCLUSION: IT WAS LATER COMMUNICATED THAT THE PATIENT EXPIRED DUE TO CARDIOGENIC SHOCK. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.
SECTION D4 (MODEL NUMBER): CORRECTION NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.
RELATED MANUFACTURER REPORT NUMBER: 2916596-2022-01241. IT WAS REPORTED THAT THE PATIENT'S LOG FILES WERE SUBMITTED FOR REVIEW CONCERNING DRIVELINE COMMUNICATION FAULT ALARMS. THE PATIENT CAME TO THE EMERGENCY ROOM (ER) WITH DRIVELINE COMMUNICATION FAULT ALARMS AND PUMP STOP ALARMS. A REVIEW OF THE LOG FILE REVEALED THAT THE PATIENT WAS CONNECTED TO FULLY CHARGED BATTERIES ON (B)(6) 2022 AT 1618:28. A POWER SOURCE EXCHANGE WAS MADE AT (B)(6) 2022 AT 0527:35. THE LOG FILE INDICATED THAT THE DRIVELINE WAS DISCONNECTED FROM THE CONTROLLER ON (B)(6) 2022 AT 0529:14. WHILE THE DRIVELINE WAS STILL DISCONNECTED, THE CONTROLLER WAS CONNECTED TO MOBILE POWER UNIT (MPU) POWER ON (B)(6) 2022 AT 0546:26. WHILE THE DRIVELINE WAS STILL DISCONNECTED, THE CONTROLLER WAS SWITCHED BACK TO BATTERY POWER ON (B)(6) 2022 AT 0606:44. THE DRIVELINE WAS RECONNECTED TO THE CONTROLLER WHILE ON BATTERY POWER ON (B)(6) 2022 0615:38. MOTOR SPEED WAS INCREASED TO THE SET SPEED OF 5000 RPMS HOWEVER THE CONTROLLER INDICATED THAT THE DRIVELINE POWER FAULT WAS ASSOCIATED WITH AN OPEN FUSE IN THE SYSTEM CONTROLLER. THE LOG FILE INDICATED THE CONTROLLER¿S POWER SOURCE WAS SWITCHED FROM BATTERY POWER TO POWER MODULE POWER ON (B)(6) 2022 AT 0658:46. DRIVELINE POWER FAULT EVENTS CONTINUED. THE SYSTEM CONTINUED TO MAINTAIN ITS SET SPEED UNTIL ANOTHER DRIVELINE FAULT OCCURRED ON (B)(6) 2022 AT 0749:22. ADDITIONAL INFORMATION REVEALED THAT THE PATIENT PASSED AWAY. THEY WERE FOUND UNRESPONSIVE AND WAS BROUGHT TO THE ER BY EMERGENCY RESPONDERS.
RELATED MANUFACTURER'S REPORT NUMBER: 2916596-2022-01745.
ADDITIONAL INFORMATION REVEALED THAT THE PATIENT PASSED AWAY DUE TO CARDIOGENIC SHOCK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 279296 | THORATEC® HEARTMATE 3® LVAS IMPLANT KIT | VENTRICULAR (ASSISST) BYPASS | DSQ | THORATEC CORPORATION | 106524US | 00813024013297 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Female | Death |