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

Model Number 397002-001

Device Problem Audible Prompt/Feedback Problem (4020)

Patient Problem No Patient Involvement (2645)

Event Date 09/13/2019

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses low risk to a patient because the issue was observed when the freedom driver was not supporting a patient.The freedom driver has been returned to syncardia for evaluation.The results of the investigation 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 had a system malfunction alarm when it was turned on.

Manufacturer Narrative

Review of the patient file data did not reveal a recorded system malfunction alarm.A computer malfunction alarm was found to be recorded in the driver instead.This alarm is generated when there is either a sudden loss of communication between the left and right embedded supervisors or a sudden loss of power that causes the driver to not shut down properly.This alarm will only appear on the next power cycle to alert the user that there had been a sudden loss of power.All other alarms that were occurring at the time would be lost.If the customer-reported system malfunction alarm occurred before the computer malfunction alarm, that alarm would have no longer been recorded in the driver.The driver's alarm history data was extracted and reviewed.Fault code 42, "other es has not communicated within time-out period," was found to have been recorded for the left embedded supervisor (les) and right embedded supervisor (res).These findings correspond with the computer malfunction alarm.Functional testing and an additional extended observation run were performed.During these tests no alarms occurred and the driver functioned as intended.It cannot be conclusively determined what caused the computer malfunction alarm or the system malfunction alarm reported by the customer.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation of this complaint and is closing this file.(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
• MDR Report Key: 9141509
• MDR Text Key: 161040355
• Report Number: 3003761017-2019-00284
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2019
• 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: 09/23/2019
• Date Manufacturer Received: 09/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1