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

Catalog Number 397001-001

Device Problem Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Date 09/17/2019

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 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 driver caddy was not in patient use.The companion driver caddy is a small cart with wheels into which the companion 2 driver docks.It is designed to facilitate mobility of stable patients while in the hospital.The caddy can be plugged into external wall power to provide a redundant power source to the docked companion 2 driver.The customer, a syncardia authorized warehouse, reported that the companion driver caddy handle was stuck and no longer working.

Manufacturer Narrative

Investigational testing confirmed the customer-reported issue as the caddy handle did not lock into place when extended fully or in the collapsed position.The handle block assembly was found to be out of position with the handle latch assembly.This most likely occurred due to rough handling of the caddy.After adjusting the handle block assembly to its proper position, the caddy passed all sections of functional testing.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.Ce 4970 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: 9141515
• MDR Text Key: 161041292
• Report Number: 3003761017-2019-00288
• 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: foreign,other
• Type of Report: Initial,Followup
• Report Date: 12/16/2019

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: Other
• Device Catalogue Number: 397001-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2019
• Date Manufacturer Received: 09/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1