MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM ONBOARD BATTERY

Catalog Number	295025-001
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
The freedom onboard battery will be returned to syncardia for evaluation.The results will be provided in a follow-up mdr.(b)(4) initial (2 of 3).
Event or Problem Description
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 45977 (mfr report # 3003761017-2022-00109); (2) freedom onboard battery s/n 45879 (mfr report # 3003761017-2022-00110); (3) freedom battery charger s/n 255).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.
Additional Manufacturer Narrative
Device history record (dhr) review confirmed that freedom battery 45879 was serviced and passed all functional testing prior to being released to finished goods.Data file review found battery had a cycle count of 477 with a limit of 300 pushing it functionally out of specification.Visual inspection of external components found no abnormalities.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.

• Brand Name: SYNCARDIA FREEDOM ONBOARD BATTERY
• Common Device Name: BATTERY
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e silverlake road; tucson AZ 85713
• Manufacturer (Section G): SYNCARDIA SYSTEMS, LLC; 1992 e silverlake road; tucson AZ 85713
• Manufacturer Contact: maia kirk ; 1992 e silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 15631917
• Report Number: 3003761017-2022-00110
• Device Sequence Number: 14942644
• Product Code: LOZ
• UDI-Device Identifier: 00858000003084
• UDI-Public: (01)00858000003084
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P030011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 295025-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/27/2022
• Supplement Date Received by Manufacturer: 09/27/2022
• Initial Report FDA Received Date: 10/19/2022
• Supplement Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown