THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER
Report
- Report Number
- 2916596-2024-05264
- Event Type
- Malfunction
- Date Received
- August 13, 2024
- Date of Event
- August 17, 2022
- Report Date
- October 16, 2024
- Manufacturer
- THORATEC CORPORATION
- Product Code
- DSQ
- UDI-DI
- 00813024013235
- PMA / PMN Number
- P160054
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.
MANUFACTURER'S INVESTIGATION CONCLUSION: THE INVESTIGATION CONFIRMED THE REPORTED UNDOCUMENTED CONTROLLER EXCHANGE ON 17AUG2022 VIA SUBMITTED LOG FILES (BACKUP BATTERY FAULTS AND ALARMS COVERED IN CS-193159/PI-2024-0034602-01). FROM ADDITIONAL INFORMATION IT WAS DETERMINED THAT A BACKUP BATTERY EXCHANGE OCCURRED ON THE SAME DATE, 17AUG2022, AS THE UNDOCUMENTED CONTROLLER EXCHANGE. IT WAS CONFIRMED THE BACKUP BATTERY WAS EXCHANGED IN AN ATTEMPT TO RESOLVE THE RECURRING BACKUP BATTERY FAULT ALARMS, BUT THE REASON FOR THE CONTROLLER EXCHANGE IS UNKNOWN AS THERE IS NO DOCUMENTATION RELATED TO IT. A ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED THROUGH THIS ANALYSIS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE RECORDS REVEALED THE HEARTMATE 3 SYSTEM CONTROLLER (SERIAL NUMBER: (B)(6)) WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. IT WAS NOTED THAT THIS CONTROLLER WAS ORIGINALLY PACKAGED WITH BACKUP BATTERY GQ308029. THE INITIAL TESTING RECORDS WERE REVIEWED FOR BACKUP BATTERY GW161055, AND IT WAS OBSERVED TO PASS INITIAL TESTING. HEARTMATE 3 INSTRUCTIONS FOR USE (REV. C) SECTION 2 ENTITLED ¿SYSTEM OPERATIONS¿ ADDRESSES HOW TO REPLACE A RUNNING SYSTEM CONTROLLER WITH A BACKUP SYSTEM CONTROLLER. HEARTMATE 3 PATIENT HANDBOOK (REV. D) SECTION 2 ENTITLED ¿HOW YOUR HEART PUMP WORKS¿ EXPLAINS HOW TO EXCHANGE THE CONTROLLER WITH ONE OR MULTIPLE POWER SOURCES. HEARTMATE 3 INSTRUCTIONS FOR USE (REV. C) SECTION 7 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE 3 PATIENT HANDBOOK (REV. D) SECTION 5 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ ADDRESSES HOW TO PROPERLY INTERPRET AND TROUBLESHOOT ALL SYSTEM ALARMS. HEARTMATE 3 INSTRUCTIONS FOR USE (REV. C) SECTION 8 ENTITLED ¿CARING FOR THE EQUIPMENT¿ AND HEARTMATE 3 PATIENT HANDBOOK (REV. D) SECTION 6 ENTITLED ¿CARING FOR THE EQUIPMENT¿ ADDRESSES HOW TO PROPERLY CARE FOR, MAINTAIN, AND STORE THE EQUIPMENT FOR PROPER USE. 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. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.
NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.
IT WAS REPORTED THAT THE PERIODIC LOG FILE INDICATED THAT THE SYSTEM CONTROLLER WAS IN PATIENT USED FROM (B)(6) 2022. SOMETIME BETWEEN (B)(6) 2022, THE CONTROLLER WAS EXCHANGED TO ANOTHER ONE. IT WAS NOTED THAT THERE WERE BACKUP BATTERY FAUL ALARMS BETWEEN (B)(6) 2022 AT 21:44:30 TO (B)(6) 2022 AT 12:43:58 BEFORE THE CONTROLLER WAS EXCHANGED.
ADDITIONAL INFORMATION WAS PROVIDED THAT PER THE AVAILABLE DOCUMENTATION, THE BACKUP BATTERY WAS EXCHANGED ON (B)(6) 2022 AT AN OUTPATIENT APPOINTMENT. HOWEVER, THERE WAS NO DOCUMENTATION TO SUPPORT THE CONTROLLER EXCHANGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1640539 | THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER | VENTRICULAR (ASSIST) BYPASS | DSQ | THORATEC CORPORATION | 106531US | 00813024013235 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Male |