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

Model Number 397002-001

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Patient Involvement (2645)

Event Date 12/04/2018

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk because the reported issue was observed when the companion 2 driver was not supporting a patient.The companion 2 driver has been 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 hospital, reported that the companion 2 driver did not recognize multiple replacement external batteries which worked in other companion 2 drivers.

Manufacturer Narrative

The customer-reported issue of the driver not detecting external batteries during system checkout was not able to be reproduced during investigation testing.The driver's patient file data and alarm history were reviewed and revealed battery-related alarms that could have been caused either from lack of recognition (depleted batteries) or from the batteries being removed as part of the system checkout.The driver will only record alarms and notifications while the driver is on; the status of any batteries in the driver when the driver is off is not recorded.This investigation found that the driver functioned as intended and passed all requirements.Additionally, external batteries that have previously met performance requirements were used to test the ability of the driver to recognize and charge external batteries, which the driver was able to do.The external batteries used and referenced in the customer-reported issue were not returned and therefore could not be evaluated as part of this investigation.The root cause of the customer-reported issue of the driver not detecting external batteries during system checkout cannot be conclusively determined without the evaluation of the external batteries used, but it is likely that the external batteries in use were severely depleted, which is not a malfunction of the driver.This conclusion is supported by the driver's ability to charge and recognize other external batteries properly.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: 8186728
• MDR Text Key: 131382635
• Report Number: 3003761017-2018-00559
• 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: 05/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• 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: 12/06/2018
• Date Manufacturer Received: 12/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1