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

Catalog Number 397003-001

Device Problems Disconnection (1171); Difficult to Insert (1316)

Patient Problems No Consequences Or Impact To Patient (2199); 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 although the power locking cord on the hospital cart did not stay plugged in, 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 investigation will be provided in a follow-up mdr.(b)(4) initial.

Event Description

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 certified hospital, reported that the locking power cord did not stay plugged into the hospital cart.

Event Description

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 certified hospital, reported that the locking power cord did not stay plugged into the hospital cart.

Manufacturer Narrative

The companion hospital cart was returned to syncardia for evaluation.Visual inspection revealed the hospital cart power entry module ground pin had been broken off and was locked into the returned locking power cord.The customer-reported issue of the locking power cord not being able to stay in the hospital cart was confirmed.The locking mechanism in the locking power cord attaches to the ground pin of the power entry module on the hospital cart.If the ground pin of the power entry module is missing, the locking power cord does not have anything to attach to and therefore will not lock in place.After pressing the locking power cord release mechanism during investigation testing, the ground pin became free from the locking power cord.This confirmed that the power locking cord release mechanism was working properly.It is possible that the locking power cord was forcibly pulled from the hospital cart without pressing the release mechanism, causing the ground pin to become disconnected from the power entry module.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 HOSPITAL CART
• Type of Device: HOSPITAL CART
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• MDR Report Key: 7173312
• MDR Text Key: 97729106
• Report Number: 3003761017-2018-00012
• 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: health professional,user faci
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 12/29/2017

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: Health Professional
• Device Catalogue Number: 397003-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 30 YR