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

Model Number 397002-001

Device Problem Output Problem (3005)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/27/2020

Event Type  malfunction  

Manufacturer Narrative

The companion 2 driver will be evaluated by syncardia.The results of the investigation will be provided in a follow-up mdr.(b)(4).

Event Description

While performing a routine evaluation, a syncardia technician reported that the companion 2 driver functional test results were outside of the acceptance criteria.

Manufacturer Narrative

The reported issue was reproduced during investigation testing.The root cause of the left driveline pressure being out of specification was determined to be a malfunction of the left electronic pressure regulator.Syncardia has a corrective and preventive action (capa) to address electronic pressure regulators.Syncardia has completed its investigation and is closing this file.Ce 5360 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
• MDR Report Key: 10502766
• MDR Text Key: 205937964
• Report Number: 3003761017-2020-00195
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003107
• UDI-Public: (01)00858000003107
• Combination Product (y/n): N
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 397002-001
• Device Catalogue Number: 397002-001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1