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	09/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Per hospital staff, patient on companion 2 driver had an alarm for "left incorrect pressure reading".Patient was switched to a backup driver without any reported adverse impact.
Event or Problem Description
Per hospital staff, patient on companion 2 driver had an alarm for "left incorrect pressure reading".Patient was switched to a backup 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 left pressure incorrect alarms recorded in the driver's data file.Visual inspection of external and internal components found no abnormalities.Driver passed all areas of functional testing for acceptance at incoming inspection.When the driver was set to the same settings as the customer when the reported alarm occurred, the left pressure incorrect alarm was replicated.The customer settings, however, were not the normotensive settings for the device and the driver was connected to a mock tank set to normotensive settings.The discrepancies in the driver settings likely caused overpressure alarms.When the vacuums were dropped, the driver alarms cleared and functioned without issue.Although the customer complaint was replicated, it was not evidence of a device malfunction.Failure investigation for this complaint confirmed the reported issue from the alarm history.The customer complaint was replicated during functional testing while driver was set to abnormal settings; the root cause of the reported left pressure incorrect alarms was unable to be determined.Failure investigation identified no test failures or damage that could have contributed to the reported complaint.The driver settings are outlined in the provided user manuals and point to the appropriate systole settings.It is reiterated in the manual that settings outside the requirements specifications will likely result in an alarm.No evidence of a device malfunction was found.The patient was switched to a backup driver without reported adverse impact.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 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: 20348798
• Report Number: 3003761017-2024-00115
• Device Sequence Number: 8046187
• Product Code: LOZ
• UDI-Device Identifier: 00858000003107
• UDI-Public: (01)00858000003107
• 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): 01/10/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/24/2024
• Supplement Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 01/10/2025
• 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 Age: 53 YR
• Patient Sex: Male