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

Model Number CSS CONSOLE

Device Problems Device Operates Differently Than Expected (2913); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Date 07/13/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4) initial.

Event Description

This css console was not supporting a patient.The customer reported that there was a loud hissing sound when the reserve air tank was opened.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 css console will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.

Manufacturer Narrative

The css console was returned to syncardia for evaluation.The root cause of the reported issue was the malfunction of a high pressure o-ring to securely seal against the air tank valve.This is a component that is serviceable by the customer with a tool kit, replacement o-rings, and instructions for replacement provided with the css console.When any css console is shipped from syncardia, a tool kit (p/n350041-001) is issued to it and will travel with the css console whenever the css console is shipped to different locations.Within that tool kit are replacement o-rings that can be used if needed to be replaced in the field.Instructions on replacing the o-rings are provided in the circulatory support system (css) and wcomdu user's manual (p/n 950001-001) at section 5.4.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.

Event Description

This css console was not supporting a patient.The customer reported that there was a loud hissing sound when the reserve air tank was opened.

• 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: 5836835
• MDR Text Key: 52284616
• Report Number: 3003761017-2016-00275
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 07/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2016
• 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: 11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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