MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA 70CC TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T); BIVENTRICULAR REPLACEMENT DEVICE

Catalog Number	P/N 500101
Medical Device Problem Codes	Contamination (1120); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturing and production of the device will be evaluated, and the results will be provided in a follow-up mdr.
Event or Problem Description
The customer, a (b)(6)hospital, reported that a hair was found within the sterile packaging of one of the 25mm pressure test plugs.The item and packaging were disposed of, and the surgical spares kit was opened to obtain another 25mm pressure test plug.
Additional Manufacturer Narrative
Dhr review confirms the tah device was manufactured in accordance with all specification requirements and met all inspection, test and sterilization requirements before being released to finished goods.The implant kit includes pressure test plugs utilized to test the device following implant prior to closing the chest to ensure the device was implanted properly, however, these are sterilized and packaged separately from the implanted ventricles.The contaminated test plug was discarded in the or and not returned for investigation.Review of photographic evidence provided with the complaint confirmed a hair was inside the sterile packaging for the test plug.Failure investigation for this complaint confirmed the reported issue from the photographic evidence provided.No additional testing could be completed as the product was discarded and not returned.The root cause of the reported contamination could not be conclusively determined.Pressure test plug couldn't be used for intended purpose because of the hair found in the packaging.This issue is an isolated incident and has not been reported prior to or after this complaint.No patient impact reported, tah was successfully implanted.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.
Event or Problem Description
The customer, a syncardia certified hospital, reported that a hair was found within the sterile packaging of one of the 25mm pressure test plugs.The item and packaging were disposed of, and the surgical spares kit was opened to obtain another 25mm pressure test plug.

• Brand Name: SYNCARDIA 70CC TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T)
• Common Device Name: BIVENTRICULAR REPLACEMENT DEVICE
• 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: michael larsen ; 1992 e silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 16835107
• Report Number: 3003761017-2023-00059
• Device Sequence Number: 6591756
• Product Code: LOZ
• UDI-Device Identifier: 00858000003008
• UDI-Public: (01)00858000003008
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 05/30/2025

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: P/N 500101
• Device Lot Number: 126287
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2023
• Supplement Date Received by Manufacturer: 04/16/2023
• Initial Report FDA Received Date: 04/28/2023
• Supplement Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown