MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE; EXTERNAL PNEUMATIC DRIVER

Model Number CSS CONSOLE

Device Problems Break (1069); Image Display Error/Artifact (1304); Device Operates Differently Than Expected (2913); Device Operational Issue (2914)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 09/21/2016

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to a patient because the issue was observed when the css console was not supporting a patient.In addition, it would not prevent the css console from performing its life-sustaining functions.The computer is a monitoring device only and does not control css console functionality.The css console will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4).

Event Description

This css console was not supporting a patient.The customer reported that the monitoring laptop computer on the css console had four lines on the computer screen.The customer also reported that the css console had a broken rear left castor.

Manufacturer Narrative

The css console was returned to syncardia for evaluation.The reported issues, four lines on the monitor and a bad caster, were confirmed and reproduced during investigation testing.The monitor was found to have additional lines across the monitor during this investigation; however, the lcd screen still displayed all information visibly with normal contrast.The caster was found to have a damaged raceway but damage was insufficient to cause caster to improperly perform its functions and it continued performing as intended.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).

Event Description

This css console was not supporting a patient.The customer reported that the monitoring laptop computer on the css console had four lines on the computer screen.The customer also reported that the css console had a broken rear left castor.

• Brand Name: SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE
• Type of Device: EXTERNAL PNEUMATIC DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake rd.; tucson AZ 85713
• Manufacturer Contact: michael garippa ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 5993557
• MDR Text Key: 56807180
• Report Number: 3003761017-2016-00327
• 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: 09/21/2016

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 Model Number: CSS CONSOLE
• Device Catalogue Number: 400207
• Device Lot Number: 1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/21/2016
• Initial Date FDA Received: 10/03/2016
• Supplement Dates Manufacturer Received: 01/22/2018
• Supplement Dates FDA Received: 01/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2016
• 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