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

Catalog Number 397002-001

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/17/2023

Event Type  malfunction  

Event Description

Patient's primary c2 driver was due for 90 day service.When attempting to switch patient over to back-up driver 10095a, they were unable to make the connection at the driveline connection port.They immediately put patient back on original primary driver.After speaking with clin spec, they got non-clinical drivelines and were able to make a connection but with great difficulty so they are not comfortable using this driver.

Event Description

Patient's primary c2 driver was due for 90 day service.When attempting to switch patient over to back-up driver (b)(6), they were unable to make the connection at the driveline connection port.They immediately put patient back on original primary driver.After speaking with clin spec, they got non-clinical drivelines and were able to make a connection but with great difficulty so they are not comfortable using this driver.

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 no new alarms.Visual inspection of external components found no abnormalities.Visual inspection of internal components found dented capacitors on power management board unrelated to customer complaint.Driver passed all sections of functional testing for acceptance at incoming inspection.A series of driveline connections were performed with a variety of drivelines without issue or any malfunction.Complaint could not be replicated.Failure investigation for this complaint could not confirm the reported issue.The customer complaint could not be replicated; root cause of the driveline connection issues could not be determined.Failure investigation identified no test failures or damage that could have contributed to the complaint.There was no evidence of a device malfunction found.Patient was put on initial 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
• Type of Device: 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: aaron meier ; 1992 e silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 18080655
• MDR Text Key: 328431337
• Report Number: 3003761017-2023-00155
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 397002-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Male