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	11/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
System malfunction alarm annunciated during implantation of patient in hospital or.Upon initiating the vacuum to an out of specification setting, syncardia clinical affairs representative suggested that hospital staff increase to vacuum settings to avoid an alarm on the c2 driver.Syncardia rep explained that initiating vacuum at a lower setting, can sometimes trigger this alarm and that it is preferable to begin at a higher setting to avoid this issue.When the system malfunction alarm was active, low fill volumes (fv) on both the left and right sides were observed.Although the waveforms appeared normal, they did not correspond to the measured fv or cardiac output (co).At that time, the central venous pressure (cvp) was elevated.Following the transition to the backup system, there was a marked improvement.The fill volumes stabilized, and the co increased within specifications and patient¿s cvp decreased to within specifications.No further alarms or system issues were observed after the switch to backup driver.No adverse impact to patient reported.
Event or Problem Description
System malfunction alarm annunciated during implantation of patient in hospital or.Upon initiating the vacuum to an out of specification setting, syncardia clinical affairs representative suggested that hospital staff increase to vacuum settings to avoid an alarm on the c2 driver.Syncardia rep explained that initiating vacuum at a lower setting, can sometimes trigger this alarm and that it is preferable to begin at a higher setting to avoid this issue.When the system malfunction alarm was active, low fill volumes (fv) on both the left and right sides were observed.Although the waveforms appeared normal, they did not correspond to the measured fv or cardiac output (co).At that time, the central venous pressure (cvp) was elevated.Following the transition to the backup system, there was a marked improvement.The fill volumes stabilized, and the co increased within specifications and patient's cvp decreased to within specifications.No further alarms or system issues were observed after the switch to backup driver.No adverse impact to patient reported.
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 a system malfunction alarm record in the driver's data file.Visual inspection of internal and external components found no abnormalities.Driver failed functional testing for acceptance at incoming inspection due to a system malfunction alarm.Historical investigations indicated the pressure sensor pcba was likely the cause.A known functional pressure sensor was installed and driver was retested without alarm or issue.Failure investigation for this complaint confirmed the reported issue during alarm data review.The customer complaint was replicated during functional testing; the root cause of the reported system malfunction alarm was determined to be a nonconforming pressure sensor board due to defective pressure sensors for the left vacuum and for the right vacuum.Failure investigation identified no other test failures or damage that could have contributed to the reported issue.This is a known issue that is currently being addressed.The patient was switched to a backup driver without any 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: 20859590
• Report Number: 3003761017-2024-00126
• Device Sequence Number: 4032227
• Product Code: LOZ
• UDI-Device Identifier: 00858000003107
• UDI-Public: (01)00858000003107
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/21/2025

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: 11/19/2024
• Supplement Date Received by Manufacturer: 11/19/2024
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 03/21/2025
• 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: 21 YR
• Patient Sex: Male