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

Catalog Number 397003-001

Device Problem Material Integrity Problem (2978)

Patient Problem No Patient Involvement (2645)

Event Date 01/28/2020

Event Type  malfunction  

Manufacturer Narrative

The companion hospital cart 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 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 companion hospital cart was not supporting a patient.The customer, a syncardia certified hospital, reported that the ac power cord was unable to lock into the cart.

Manufacturer Narrative

Visual inspection and physical observation confirmed the customer-reported issue of the ac power cord not being able to lock into the companion hospital cart.The root cause of the power cord not being able to lock into the hospital cart was damage to the power entry module grounding pin, which had been scraped and worn on the bottom side.The cause for this damage cannot be conclusively determined; however, it was most likely caused by the locking mechanism not being disengaged (by pushing the button down) when inserting or removing the power cord.This would cause the scraping of metal observed on the grounding pin, causing it to wear down, and eventually not allowing the mechanism to lock onto the grounding pin.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
• MDR Report Key: 9722238
• MDR Text Key: 194394139
• Report Number: 3003761017-2020-00065
• 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
• Type of Report: Initial,Followup
• Report Date: 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2020
• 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: 02/04/2020
• Date Manufacturer Received: 01/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1