MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION HOSPITAL CART

Catalog Number 397003-001

Device Problems Electrical /Electronic Property Problem (1198); Image Display Error/Artifact (1304)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/28/2019

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because it did not prevent the companion 2 driver from performing its life sustaining functions.The companion hospital cart will be returned to syncardia for evaluation.The results of the evaluation will be provided in a follow-up mdr.(b)(4), initial (2 of 2).

Event Description

The reported issue is reported under two separate medical device reports: (1) companion 2 driver s/n (b)(4) (mfr report #3003761017-2019-00058) and (2) companion hospital cart s/n (b)(4) (mfr report # 3003761017-2019-00059).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, a syncardia authorized distributor, reported that the hospital cart screen became pink when the companion 2 driver driveline was manipulated.

Manufacturer Narrative

The companion 2 driver and hospital cart passed all incoming tests.Both the cart and driver were evaluated together where the driver was docked into the cart ten times.After each docking, the drivelines were manipulated and no issues were observed on the cart display.The customer-reported experience of the pink hospital cart screen when the driveline on the companion 2 driver was manipulated was only able to be reproduced when the companion 2 driver was improperly installed into the hospital cart and missed the docking guide.This prevented proper electrical connection for docking the driver into the cart and caused the cart screen to change to a pink color when manipulated.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 4708 follow-up report 1 (2 of 2).

• Brand Name: SYNCARDIA COMPANION HOSPITAL CART
• Type of Device: CART
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• MDR Report Key: 8444545
• MDR Text Key: 139596540
• Report Number: 3003761017-2019-00059
• 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: 06/06/2019

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: 04/24/2019
• Initial Date Manufacturer Received: 03/15/2019
• Initial Date FDA Received: 03/22/2019
• Supplement Dates Manufacturer Received: 03/15/2019
• Supplement Dates FDA Received: 06/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 47 YR