THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER
Report
- Report Number
- 2916596-2023-08614
- Event Type
- Malfunction
- Date Received
- December 14, 2023
- Date of Event
- December 7, 2023
- Report Date
- June 4, 2024
- Manufacturer
- THORATEC CORPORATION
- Product Code
- DSQ
- UDI-DI
- 00813024013235
- PMA / PMN Number
- P160054
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
MANUFACTURER¿S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF THE SYSTEM CONTROLLER (SERIAL NUMBER: (B)(6) ) GETTING "VERY WARM" AND THE BACKUP BATTERY MELTING TO THE BACK COVER WAS NOT CONFIRMED. THE SYSTEM CONTROLLER WAS NOT RETURNED FOR EVALUATION AND NO PHOTOS WERE SUBMITTED FOR REVIEW. 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 INSTRUCTIONS FOR USE SECTION 2-¿SYSTEM OPERATIONS¿ AND HEARTMATE 3 PATIENT HANDBOOK SECTION 2-¿HOW YOUR HEART PUMP WORKS¿ URGES THE USER TO NOT PLACE THE SYSTEM CONTROLLER ON BARE SKIN FOR AN EXTENDED TIME. THE SYSTEM CONTROLLER SURFACE TEMPERATURE CAN BECOME UNCOMFORTABLY WARM, ESPECIALLY WHEN THE ROOM TEMPERATURE IS ABOVE 104°F (40°C). HEARTMATE 3 INSTRUCTIONS FOR USE (IFU)SECTION 2 ¿SYSTEM OPERATIONS¿ AND SECTION 8 ¿EQUIPMENT STORAGE AND CARE¿ AND HEARTMATE 3 PATIENT HANDBOOK SECTION 9 ¿TESTING AND CLASSIFICATION¿ LISTS THE ACCEPTABLE OPERATING TEMPERATURE RANGES FOR ALL EQUIPMENT, INCLUDING THE SYSTEM CONTROLLER. THE ACCEPTABLE OPERATING TEMPERATURE RANGE FOR THE SYSTEM CONTROLLER IS 32 ¿ 104 DEGREES FAHRENHEIT (0 ¿ 40 DEGREES CELSIUS). 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.
NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.
SECTION D1, BRAND NAME: CORRECTED; SECTION D4, CATALOG NUMBER: CORRECTED; SECTION D4, PRIMARY UDI NUMBER: CORRECTED. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.
ITT WAS REPORTED THAT THE CONTROLLER WAS EXCHANGED BECAUSE THE CONTROLLER WAS VERY WARM, AND THE BACKUP BATTERY WAS MELTED TO THE BACK COVER. THE PATIENT WAS ASYMPTOMATIC DURING EXCHANGE.
IT WAS REPORTED THAT LOG FILES WERE SUBMITTED FOR REVIEW AND CAPTURED WHAT APPEARED TO BE A SYSTEM CONTROLLER EXCHANGE. THE LOG FILE CONTAINED VERY LITTLE DATA. THE FILE ENDED WITH THE PUMP RUNNING AT 5300 REVOLUTIONS PER MINUTE AND THE FLOW AT 2.5 LITERS PER MINUTE. THE PERIODIC LOG DID NOT HAVE ENOUGH DATA TO ANALYZE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 327536 | THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER | VENTRICULAR (ASSIST) BYPASS | DSQ | THORATEC CORPORATION | 106531US | 7807732 | 00813024013235 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Male |