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

Model Number 397002-001

Device Problems Display or Visual Feedback Problem (1184); Computer Operating System Problem (2898)

Patient Problems No Patient Involvement (2645); No Information (3190)

Event Date 02/14/2018

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to a patient because the issue was observed when the companion 2 driver was not supporting a patient.The companion 2 driver will be returned to syncardia for evaluation.The results of the evaluation 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 warehouse, reported that when the companion 2 driver was turned on, it showed an improper user interface boot-up screen.

Manufacturer Narrative

The customer-reported issue of the companion 2 driver displaying the improper user interface at boot up was not confirmed, as each time the driver was powered up the standard user interface appeared, rather than the bios menu.Testing conducted in this investigation showed that the 3 volt battery located on the main board was operating at a lower voltage than what is required by the system to maintain bios settings through power down, which is also known as deep cell depletion.When this occurs, the driver will not have the required voltage needed to maintain settings stored in the device memory, leading to a prompt to the user to reprogram the bios at boot up, as that data would be lost at each instance of power down without a functioning cmos battery.While, it cannot be confirmed that deep cell depletion is what caused the customer to see the bios screen, it is the most likely reason given that the driver is designed to use the functioning cmos battery to save these settings while the driver is turned off.The root cause of the cmos battery reaching deep cell depletion could not be determined, but can frequently be observed in batteries of this chemistry because of shelf life expiration.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation 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: 7302574
• MDR Text Key: 101476435
• Report Number: 3003761017-2018-00074
• 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: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 06/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2018
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1