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

Catalog Number P/N 397002-001

Device Problems Pressure Problem (3012); Audible Prompt/Feedback Problem (4020)

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

Event Date 05/11/2023

Event Type  malfunction  

Event Description

A syncardia clinical support specialist reported the companion 2 driver did not pass system check 3 consecutive times at a user facility.

Manufacturer Narrative

The companion 2 driver will be returned to syncardia for evaluation.The results will be provided in a follow-up mdr.

Manufacturer Narrative

Patient data file review revealed three failed system checks at customer site, confirming the reported issue.All three of these tests failed the "max" left vacuum tests, where the left maximum vacuum was greater than the specification requirement (-30 to -45 mmhg); actual values were -46 mmhg and -47 mmhg.Visual inspection of internal components identified capacitor damage on the power management board.Capacitor damage is unrelated to the system check failure.Visual inspection of external components revealed no abnormalities.During the investigation, the companion 2 driver passed the system check, indicating vacuums were functioning as intended.But, as a precaution, both vacuums were replaced.The companion 2 driver failed functional testing where left drive pressure was below specification requirements.The root cause of the failure was the electronic pressure regulator.The electronic pressure regulator was rejected and replaced.Functional testing was then repeated with passing results.Failure investigation for this complaint confirmed the system check failure via patient data file review, which showed three system check failures recorded in the driver.The system check failure was not replicated via functional/observational testing.The root cause of the system check failure is vacuum pressure exceeding acceptable range allowed during system check.The root cause of the device malfunction identified during functional testing was the electronic pressure regulator, which caused the left drive pressure to not meet specification requirements.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.) (b)(4) follow-up report 1.

• 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: 16997710
• MDR Text Key: 315912675
• Report Number: 3003761017-2023-00077
• 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: Other,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/06/2023

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
• Device Catalogue Number: P/N 397002-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/11/2023
• Initial Date FDA Received: 05/24/2023
• Supplement Dates Manufacturer Received: 05/11/2023
• Supplement Dates FDA Received: 07/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2017
• 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