SYNCARDIA FREEDOM ONBOARD BATTERY
Report
- Report Number
- 3003761017-2022-00109
- Event Type
- Malfunction
- Date Received
- October 21, 2022
- Date of Event
- September 27, 2022
- Report Date
- July 24, 2024
- Manufacturer
- SYNCARDIA SYSTEMS, LLC
- Product Code
- LOZ
- UDI-DI
- 00858000003084
- PMA / PMN Number
- P030011
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
THE FREEDOM ONBOARD BATTERY WILL BE RETURNED TO SYNCARDIA FOR EVALUATION. THE RESULTS WILL BE PROVIDED IN A FOLLOW-UP MDR. (B)(4) INITIAL (1 OF 3).
DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THAT FREEDOM ONBOARD BATTERY S/N (B)(6) WAS SERVICED AND PASSED ALL FUNCTIONAL TESTING PRIOR TO BEING RELEASED TO FINISHED GOODS. BATTERY S/N (B)(6) ALARM REVIEW FOUND A PERMANENT FAULT, INDICATING THE BATTERY WILL NO LONGER FUNCTION OR CHARGE/DISCHARGE. VISUAL INSPECTION OF EXTERNAL COMPONENTS FOUND SOME SEPARATION IN THE HOUSING. FREEDOM BATTERY CHARGER AND ONBOARD BATTERIES WERE ALL TESTED FOR FUNCTIONALITY. THE BATTERY CHARGER FAILED TESTING AS BAYS 1 AND 3 ARE NOT FUNCTIONAL AND DO NOT CHARGE BATTERIES. BOTH BATTERIES ALSO FAILED FUNCTIONAL TESTING DUE TO PERMANENT FAULT AND AN OUT OF SPECIFICATION CYCLE COUNT. CUSTOMER COMPLAINT WAS REPLICATED. FAILURE INVESTIGATION FOR THIS COMPLAINT CONFIRMED THE REPORTED ISSUE. THE CUSTOMER COMPLAINT WAS REPLICATED DURING INSPECTION AND TESTING; ROOT CAUSE OF THE REPORTED MALFUNCTION OF THE BATTERY CHARGER AND BATTERIES WAS DETERMINED TO BE A FAULTY FREEDOM BATTERY CHARGER AND FAULTY FREEDOM ONBOARD BATTERIES. FAILURE INVESTIGATION IDENTIFIED NO OTHER TEST FAILURES OR DAMAGE THAT COULD HAVE CONTRIBUTED TO THE COMPLAINT. SEPARATION IN THE BATTERY HOUSING WAS COSMETIC ONLY AND DID NOT AFFECT THE FUNCTIONALITY OF THE BATTERY. COMPONENTS WERE NOT IN PATIENT USE AT TIME OF COMPLAINT. THIS ISSUE WILL BE MONITORED AND TRENDED AS PART OF THE CUSTOMER COMPLAINT PROCESS. SYNCARDIA HAS COMPLETED ITS EVALUATION AND IS CLOSING THIS FILE. IF NEW OR ADDITIONAL INFORMATION IS RECEIVED IN THE FUTURE, SYNCARDIA WILL FILE A FOLLOW-UP MDR.
THE REPORTED ISSUES INVOLVE THE FOLLOWING SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM COMPONENTS AND ARE REPORTED UNDER THREE SEPARATE MEDICAL DEVICE REPORTS: (1) FREEDOM ONBOARD BATTERY S/N (B)(4) (MFR REPORT # 3003761017-2022-00109); (2) FREEDOM ONBOARD BATTERY S/N (B)(4) (MFR REPORT # 3003761017-2022-00110); (3) FREEDOM BATTERY CHARGER S/N (B)(4)). THE FREEDOM ONBOARD BATTERIES AND FREEDOM BATTERY CHARGER WERE NOT SUPPORTING A PATIENT. THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THE FREEDOM BATTERY CHARGER DID NOT CHARGE ANY FREEDOM ONBOARD BATTERIES. ADDITIONALLY, TWO FREEDOM ONBOARD BATTERIES WERE UNABLE TO CHARGE. THE CUSTOMER IS UNCLEAR IF THESE ISSUES ARE RELATED.
THE REPORTED ISSUES INVOLVE THE FOLLOWING SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM COMPONENTS AND ARE REPORTED UNDER THREE SEPARATE MEDICAL DEVICE REPORTS: (1) FREEDOM ONBOARD BATTERY S/N (B)(6) (MFR REPORT # 3003761017-2022-00109); (2) FREEDOM ONBOARD BATTERY S/N (B)(6) (MFR REPORT # 3003761017-2022-00110); (3) FREEDOM BATTERY CHARGER S/N (B)(6)). THE FREEDOM ONBOARD BATTERIES AND FREEDOM BATTERY CHARGER WERE NOT SUPPORTING A PATIENT. THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THE FREEDOM BATTERY CHARGER DID NOT CHARGE ANY FREEDOM ONBOARD BATTERIES. ADDITIONALLY, TWO FREEDOM ONBOARD BATTERIES WERE UNABLE TO CHARGE. THE CUSTOMER IS UNCLEAR IF THESE ISSUES ARE RELATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2462715 | SYNCARDIA FREEDOM ONBOARD BATTERY | BATTERY | LOZ | SYNCARDIA SYSTEMS, LLC | 00858000003084 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |