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

Catalog Number 397003-001

Device Problem Power Problem (3010)

Patient Problem No Patient Involvement (2645)

Event Date 10/03/2018

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to a patient because the issue was observed when the companion hospital cart was not supporting a patient.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).

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 authorized distributor, reported that the hospital cart would trip the power supply when plugged into wall power.

Manufacturer Narrative

Visual inspection of the exterior components revealed damage to the lcd display, display skin, and display neck bracket.It was also dirty with customer-reported dried blood.When the hospital cart docking plate was removed for visual inspection of the internal components, some ingress residue was visible on the docking plate gasket and docking plate area contacting the docking plate.The customer-reported issue, a tripping power supply, was confirmed during investigation testing when the unit was plugged into shore power.The power supply was further tested and confirmed to be nonfunctional.The cause of this malfunction cannot be determined without additional testing by an external test lab, but is likely due to a cleaning solution being pulled into the power supply's cooling fan and then being distributed across the printed circuit board (pcb).The ionic nature of the solution would essentially short all of the components it touches, which is supported by the presence of multiple clustered burn locations on the device pcb.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation and is closing this file.Ce 4495 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: 7995431
• MDR Text Key: 124814055
• Report Number: 3003761017-2018-00488
• 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: 03/20/2019

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: Other
• Device Catalogue Number: 397003-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2018
• Initial Date Manufacturer Received: 10/03/2018
• Initial Date FDA Received: 10/23/2018
• Supplement Dates Manufacturer Received: 10/03/2018
• Supplement Dates FDA Received: 03/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1