MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION DRIVER CADDY; COMPANION CADDY

Catalog Number 397002-001

Device Problem Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Date 06/18/2019

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to a patient because the issue was observed when the companion driver caddy was not in patient use.The companion driver caddy will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4).

Event Description

The companion driver caddy was not in patient use.The customer, a syncardia authorized distributor, reported that the companion driver caddy did not lock when the driver was inserted.

Manufacturer Narrative

Visual inspection confirmed the customer-reported issue of the companion 2 driver locking mechanism not working properly as the release plunger assembly was observed to be stuck in the open position.This is a known issue that has been previously documented and investigated; it determined that a lack of internal lubrication was the root cause for the release plunger assembly to be stuck in the open or closed positions.The device history records review of companion caddy indicated that the release plunger assembly was installed prior to the most current drawing, and was therefore replaced in accordance with the caddy service shop order when it was returned from the field.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 DRIVER CADDY
• Type of Device: COMPANION CADDY
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• MDR Report Key: 8746424
• MDR Text Key: 149675151
• Report Number: 3003761017-2019-00208
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 397002-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Date Manufacturer Received: 06/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1