MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION 2 DRIVER; EXTERNAL PNEUMATIC DRIVER

Catalog Number	P/N 397002-001
Medical Device Problem Code	Audible Prompt/Feedback Problem (4020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
C2 driver spontaneously alarmed system malfunction while supporting a patient.Vac had been at <13> and perfusionist dropped it to <8>; immediate vac incorrect as well as system malfunction alarm annunciated.Syncardia clinical affairs staff tried to reset the machine and was unable to clear the alarm.Patient was switched to backup c2 driver without any reported adverse impact.
Additional Manufacturer Narrative
Device history record (dhr) review confirmed that companion 2 driver s/n (b)(6) was serviced and passed all functional testing prior to being released to finished goods.Alarm history and patient data file review found two system malfunction alarms with multiple incorrect vacuum alarms.Visual inspection of internal and external components found no abnormalities.Driver passed all areas of functional testing for acceptance at incoming inspection.Additional testing included power cycling the driver five times.The system malfunction and incorrect vacuum alarms were replicated each power cycle.Historically these failures are due to the pressure sensor board.A known functional pressure sensor board was installed and the driver was left to run for 24-hours.The driver functioned as intended without issue or alarm with the replacement part.Failure investigation for this complaint confirmed the reported issue from alarm history data.The customer complaint was replicated during functional testing; the root cause of the reported system malfunction and incorrect vacuum alarms was determined to be a nonconforming pressure sensor board.Failure investigation identified no damage or other test failures that could have contributed to the event.No adverse impact to the patient was reported.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
C2 driver spontaneously alarmed system malfunction while supporting a patient.Vac had been at <13> and perfusionist dropped it to <8>; immediate vac incorrect as well as system malfunction alarm annunciated.Syncardia clinical affairs staff tried to reset the machine and was unable to clear the alarm.Patient was switched to backup c2 driver without any reported adverse impact.

• Brand Name: SYNCARDIA COMPANION 2 DRIVER
• Common Device Name: EXTERNAL PNEUMATIC DRIVER
• 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: 21103721
• Report Number: 3003761017-2025-00079
• Device Sequence Number: 12925920
• Product Code: LOZ
• UDI-Device Identifier: 00858000003107
• UDI-Public: (01)00858000003107
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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 Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2025

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 397002-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/03/2025
• Supplement Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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