SYNCARDIA 70CC TAH-T
Report
- Report Number
- 3003761017-2018-00038
- Event Type
- Malfunction
- Date Received
- February 9, 2018
- Date of Event
- January 13, 2018
- Report Date
- January 13, 2018
- Manufacturer
- SYNCARDIA SYSTEMS, LLC
- Product Code
- LOZ
- PMA / PMN Number
- P030011
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
THE TAH-T CANNULA WAS NOT RETURNED TO SYNCARDIA FOR EVALUATION AS THE TAH-T REMAINS IMPLANTED. REVIEW OF THE PHOTO SUBMITTED BY THE CUSTOMER CONFIRMED THE REPORTED DARKENED, DISCOLORED CANNULAE. IT IS LIKELY THAT THE DARKENING OF THE CANNULAE RESULTED FROM EXPOSURE TO ENVIRONMENTAL FACTORS IN THE PATIENT'S SURROUNDINGS OR FROM THE AGE OF THE MATERIAL. THIS PATTERN IS CONSISTENT WITH PREVIOUSLY-REPORTED INSTANCES OF DARKENED CANNULA. THE ROOT CAUSE OF THE DARKENED CANNULAE CANNOT BE CONCLUSIVELY DETERMINED, BUT APPEARS TO BE CONSISTENT WITH THE CANNULAE DISCOLORATION INVESTIGATED IN PREVIOUSLY WITH OTHER PATIENTS. THE FREEDOM DRIVER SYSTEM OPERATOR MANUAL (F-900012-DE) AND THE FREEDOM DRIVER SYSTEM GUIDEBOOK FOR PATIENTS AND CAREGIVERS (F-900015-DE) INSTRUCT PATIENTS TO EXAMINE THEIR CANNULAE REGULARLY AND TO NOT USE CLEANERS ON THE DRIVELINES, CANNULAE, DRIVERS OR DRIVER ACCESSORIES. USERS ARE TO USE EXTREME CARE WHEN CLEANING THE FREEDOM DRIVER AND DRIVELINES, AND TO WIPE THE DRIVELINES GENTLY WITH A SOFT, CLEAN CLOTH LIGHTLY DAMPENED ONLY WITH WATER. THIS ISSUE WILL CONTINUE TO BE MONITORED AND TRENDED AS PART OF THE CUSTOMER EXPERIENCE PROCESS. SYNCARDIA HAS COMPLETED ITS EVALUATION OF THIS COMPLAINT AND IS CLOSING THIS FILE. (B)(4) FOLLOW-UP REPORT 1.
THE TAH-T CANNULA WAS NOT RETURNED TO SYNCARDIA FOR EVALUATION AS THE TAH-T REMAINS IMPLANTED. REVIEW OF THE PHOTO SUBMITTED BY THE CUSTOMER CONFIRMED THE REPORTED DARKENED, DISCOLORED CANNULAE. IT IS LIKELY THAT THE DARKENING OF THE CANNULAE RESULTED FROM EXPOSURE TO ENVIRONMENTAL FACTORS IN THE PATIENT'S SURROUNDINGS OR FROM THE AGE OF THE MATERIAL. THIS PATTERN IS CONSISTENT WITH PREVIOUSLY-REPORTED INSTANCES OF DARKENED CANNULA. THE ROOT CAUSE OF THE DARKENED CANNULAE CANNOT BE CONCLUSIVELY DETERMINED, BUT APPEARS TO BE CONSISTENT WITH THE CANNULAE DISCOLORATION INVESTIGATED IN PREVIOUSLY WITH OTHER PATIENTS. THE FREEDOM DRIVER SYSTEM OPERATOR MANUAL (F-900012-DE) AND THE FREEDOM DRIVER SYSTEM GUIDEBOOK FOR PATIENTS AND CAREGIVERS (F-900015-DE) INSTRUCT PATIENTS TO EXAMINE THEIR CANNULAE REGULARLY AND TO NOT USE CLEANERS ON THE DRIVELINES, CANNULAE, DRIVERS OR DRIVER ACCESSORIES. USERS ARE TO USE EXTREME CARE WHEN CLEANING THE FREEDOM DRIVER AND DRIVELINES, AND TO WIPE THE DRIVELINES GENTLY WITH A SOFT, CLEAN CLOTH LIGHTLY DAMPENED ONLY WITH WATER. THIS ISSUE WILL CONTINUE TO BE MONITORED AND TRENDED AS PART OF THE CUSTOMER EXPERIENCE PROCESS. SYNCARDIA HAS COMPLETED ITS EVALUATION OF THIS COMPLAINT AND IS CLOSING THIS FILE. (B)(4) FOLLOW-UP REPORT 1.
THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT THE CANNULA ON THE TAH-T WAS TURNING BROWN-COLORED. THERE WAS NO REPORTED PATIENT IMPACT.
THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT THE CANNULA ON THE TAH-T WAS TURNING BROWN-COLORED. THERE WAS NO REPORTED PATIENT IMPACT.
THE TAH-T CANNULA WILL NOT BE RETURNED TO SYNCARDIA FOR EVALUATION AS THE TAH-T REMAINS IMPLANTED. THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A FOLLOW-UP MDR. (B)(4) INITIAL.
THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT THE CANNULA ON THE TAH-T WAS TURNING BROWN-COLORED. THERE WAS NO REPORTED PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 102867 | SYNCARDIA 70CC TAH-T | BIVENTRICULAR REPLACEMENT DEVICE | LOZ | SYNCARDIA SYSTEMS, LLC | 087171 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR |