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

Model Number 397002-001

Device Problems Device Displays Incorrect Message (2591); Device Sensing Problem (2917)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 12/27/2017

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 has been returned to syncardia for evaluation.The results of the evaluation will be provided in a follow-up mdr.(b)(4) initial.

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 external batteries.

Manufacturer Narrative

The driver in "as received" condition passed all functional test requirements.In addition, 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 alarm history was reviewed and confirmed the very low battery alarms reported by the customer.The external batteries in use at the time of the customer-reported issue were not returned with the driver and therefore were not evaluated.The root cause of this issue cannot be determined without investigating the external batteries, but it is likely that the batteries in use were severely depleted external batteries and not a malfunction of the driver.Companion external battery customer notification sheet is included with the batteries during shipment and explains that external batteries will arrive with a low charge and are likely to trigger a low external battery alarm.Users are instructed to fully charge the external batteries before inserting into a driver.The driver performed as intended and there was no evidence of a device malfunction.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: 7173311
• MDR Text Key: 97482730
• Report Number: 3003761017-2018-00010
• 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: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Model Number: 397002-001
• Device Catalogue Number: 397002-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/27/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1