MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA COMPANION HOSPITAL CART

Catalog Number 397003-001

Device Problems No Display/Image (1183); Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Date 04/12/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

This syncardia companion hospital cart was not in patient use.The syncardia companion hospital cart is a large cart with wheels into which the syncardia companion 2 driver docks.It is intended for use in the hospital during the temporary total artificial heart (tah-t) implant procedure and subsequent recovery.The customer reported that the companion hospital cart lcd monitor was blank and not working.This alleged failure mode poses a low risk to a patient because the hospital cart was not in use with a patient when the issue was observed.In addition, it would not prevent a docked companion 2 driver from performing its life-sustaining functions.The companion hospital cart will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.

Manufacturer Narrative

(b)(4).

Event Description

This syncardia companion hospital cart was not in patient use.The syncardia companion hospital cart is a large cart with wheels into which the syncardia companion 2 driver docks.It is intended for use in the hospital during the temporary total artificial heart (tah-t) implant procedure and subsequent recovery.The customer reported that the companion hospital cart lcd monitor was blank and not working.The companion hospital cart was returned to syncardia for evaluation.Visual inspection revealed that the display neck bracket was bent, but it did not affect the functionality of the lcd monitor.The hospital cart was tested, which included testing the hospital cart with a docked companion 2 driver.The hospital cart, including its lcd monitor, passed all functional testing.The reported issue of a blank lcd monitor could not be duplicated.The touchscreen interface calibrated as intended with no issues.During the investigation, the hospital cart performed as intended, and there was no evidence of a device malfunction.It is possible that the customer experienced an intermittent connection issue when the companion 2 driver was docked into the hospital cart.The hospital cart was serviced, including replacement of the display neck bracket, and passed all final performance testing.The reported issue posed a low risk to a patient because the hospital cart was not in use with a patient when the issue was observed.In addition, it would not prevent a docked companion 2 driver from performing its life-sustaining functions.The companion 2 driver has a monitor that has the same functionality as the hospital cart's monitor.The companion hospital cart is used as an accessory to the companion 2 driver, and hospitals are equipped with backup hospital carts.This issue will continue to be monitored and trended as a part of the customer experience process.Syncardia has completed its evaluation of this complaint and is closing this file.

• Brand Name: SYNCARDIA COMPANION HOSPITAL CART
• Type of Device: HOSPITAL CART
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: carole marcot ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 5626319
• MDR Text Key: 45278158
• Report Number: 3003761017-2016-00162
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 397003-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2016
• Initial Date FDA Received: 05/03/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1