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

Model Number 397002-001

Device Problems Break (1069); Fracture (1260); Mechanical Problem (1384); Material Deformation (2976); Output Problem (3005)

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

Event Date 07/30/2021

Event Type  malfunction  

Manufacturer Narrative

The companion 2 driver has been returned to syncardia for evaluation.The results will be provided in a follow-up mdr.(b)(4).

Event Description

The companion 2 driver was not supporting a patient.The customer, a syncardia certified hospital, reported that the companion 2 driver did not generate right side waveforms or data after it was powered on.

Manufacturer Narrative

The alarm history and patient data file was reviewed and confirmed that on the date of the event the driver was powered on and operated for 9 minutes.During this time, the driver ran at the patient settings of 125 bpm, left drive pressure 200 mmhg, right drive pressure 100 mmhg, left vacuum -10 mmhg and right vacuum -10 mmhg.The patient parameters showed that at this time there was no right cardiac output and no right fill volume.During this time frame there were also multiple alarms related to cardiac output and right pressure.Visual inspection of external and internal components found damage to the lcd screen and damage at two capacitor locations on the power management board.Neither of these issues are related to the customer reported complaint.This is a known cosmetic issue, and syncardia has a corrective and preventive action (capa) for the issue of companion 2 driver power management board component failures.Incoming functional testing was performed and the driver failed testing for the right side pressure and cardiac output.There were also no wave forms present on the right side.The pilot valve on the right side was suspected to be the root cause of the test failure.To confirm, the right and left side pilot valves were switched and the driver retested.After the switch, the left side waveforms were missing.The pilot valve was then replaced and the driver was tested once more.With the known good test pilot valve, the driver successfully passed all test steps, confirming the original pilot valve installed on the right side was the root cause of the complaint.The complaint was confirmed upon examination when the driver was tested as received and the waveforms on the driver showed no waveforms on the right side, as well as no right cardiac output and no right fill volume.The complaint was replicated during testing when right waveforms did not appear.The root cause of the customer reported issue is a faulty pilot valve.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: 12379720
• MDR Text Key: 268548581
• Report Number: 3003761017-2021-00161
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003107
• UDI-Public: (01)00858000003107
• 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: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 397002-001
• Device Catalogue Number: 397002-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/30/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/24/2017
• 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