HEARTMATE 3 VAD MODULAR CABLE
Report
- Report Number
- 2916596-2022-00798
- Event Type
- Malfunction
- Date Received
- February 23, 2022
- Date of Event
- January 26, 2022
- Report Date
- April 5, 2022
- Manufacturer
- THORATEC CORPORATION
- Product Code
- DSQ
- UDI-DI
- 00813024013181
- PMA / PMN Number
- P160054
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.
NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.
MANUFACTURER'S INVESTIGATION CONCLUSION. THE REPORTED EVENT OF DRIVELINE COMMUNICATION FAULTS WAS ABLE TO BE CONFIRMED VIA REVIEW OF THE LOG FILE. THE MODULAR CABLE (LOT NUMBER: 6709708) WAS NOT RETURNED FOR ANALYSIS; HOWEVER, A LOG FILE WAS SUBMITTED FOR REVIEW. A REVIEW OF THE SUBMITTED LOG FILES SHOWED EVENTS SPANNING APPROXIMATELY 5 DAYS (23JAN2022 ¿ 28JAN2022 PER TIMESTAMP). DRIVELINE COMMUNICATION FAULT ALARMS COINCIDENT WITH COM_B_FAULTS WERE ACTIVE ON 26JAN2022 AT 19:15:12 THROUGH THE END OF THE LOG FILE AT 28JAN2022 AT 08:50:56. THERE WERE NO OTHER NOTABLE ALARMS ACTIVE IN THE LOG FILE. ADDITIONAL INFORMATION PROVIDED ON 10FEB2022 STATED THAT THE REPLACED MODULAR CABLE WILL NOT BE RETURNING. ADDITIONAL INFORMATION PROVIDED ON 17FEB2022 STATED THAT THE COMMUNICATION FAULT ALARMS WERE RESOLVED AFTER THE MODULAR CABLE EXCHANGE. THE CAUSE OF THE ALARMS IS SUSPECTED TO BE CAUSED BY DAMAGE TO THE MODULAR CABLE. ADDITIONAL INFORMATION PROVIDED ON 28FEB2022 STATED THAT THE SUSPECT CAUSE OF THE ALARM WAS DUE TO DAMAGE TO THE MODULAR CABLE AND THAT THE CONTROLLER AND MODULAR CABLE WERE EXCHANGED AT THE SAME TIME. THE ROOT CAUSE OF THE REPORTED EVENT WAS UNABLE TO BE CONCLUSIVELY DETERMINED THROUGH THIS INVESTIGATION; HOWEVER, IT IS SUSPECTED TO BE CAUSED BY DAMAGE TO THE MODULAR CABLE. HEARTMATE III INSTRUCTIONS FOR USE, REV. C SECTION 7 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE III PATIENT HANDBOOK, REV. C, SECTION 5 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ ADDRESSES HOW TO PROPERLY INTERPRET AND TROUBLESHOOT ALL SYSTEM ALARMS INCLUDING DRIVELINE FAULT ALARM CONDITIONS, AND THE ACTIONS TO TAKE IF THE ALARMS CANNOT BE RESOLVED. THE PATIENT HANDBOOK CAUTIONS THE 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. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THE MODULAR CABLE (LOT NUMBER: 6709708) AND WERE FOUND TO PASS ALL MANUFACTURING AND QA SPECIFICATIONS BEFORE BEING SHIPPED TO THE CUSTOMER. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.
IT WAS REPORTED THAT THE PATIENT HAD A DRIVELINE FAULT ON (B)(6) 2022 AT 1915. A REVIEW OF THE LOG FILE REVEALED DRIVELINE COMMUNICATED FAULT ALARMS ON (B)(6) 2022 AT 1915:22. ADDITIONALLY THERE WAS A PUMP EVENT AT 1945:48 THAT APPEARED TO BE RELATED TO AN ELECTROSTATIC DISCHARGE (ESD) EVENT. THE PUMP WAS DESIGNED TO AUTOMATICALLY RESET WHEN SUBJECTED TO A HIGH STATIC DISCHARGE EVENT. THE PUMP WAS OFF FOR APPROXIMATELY 4 SECONDS DURING THIS RESET. THE DRIVELINE COMMUNICATION FAULT ALARM DID NOT RESOLVE AFTER THE PUMP STARTED BACK UP. THE PATIENT'S HEARTMATE 3 SYSTEM CONTROLLER AND MODULAR CABLE WERE REPLACED. THE DRIVELINE FAULT ALARMS RESOLVED AFTER THE EXCHANGE, AND THE HOSPITAL BELIEVES THAT THE CAUSE OF THE ALARMS WAS THE MODULAR CABLE.
IT WAS REPORTED THAT THE PATIENT HAD A DRIVELINE FAULT ON (B)(6) 2022 AT 1915. A REVIEW OF THE LOG FILE REVEALED DRIVELINE COMMUNICATED FAULT ALARMS ON (B)(6) 2022 AT 1915:22. ADDITIONALLY THERE WAS A PUMP EVENT AT 1945:48 THAT APPEARED TO BE RELATED TO AN ELECTROSTATIC DISCHARGE (ESD) EVENT. THE PUMP WAS DESIGNED TO AUTOMATICALLY RESET WHEN SUBJECTED TO A HIGH STATIC DISCHARGE EVENT. THE PUMP WAS OFF FOR APPROXIMATELY 4 SECONDS DURING THIS RESET. THE DRIVELINE COMMUNICATION FAULT ALARM DID NOT RESOLVE AFTER THE PUMP STARTED BACK UP. THE PATIENT'S HEARTMATE 3 SYSTEM CONTROLLER AND MODULAR CABLE WERE REPLACED. THE DRIVELINE FAULT ALARMS RESOLVED AFTER THE EXCHANGE, AND THE HOSPITAL BELIEVES THAT THE CAUSE OF THE ALARMS WAS THE MODULAR CABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 930427 | HEARTMATE 3 VAD MODULAR CABLE | VENTRICULAR (ASSISST) BYPASS | DSQ | THORATEC CORPORATION | 106525 | 6709708 | 00813024013181 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Male |