MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA CSS CONSOLE; EXTERNAL PNEUMATIC DRIVER

Model Number CSS CONSOLE

Device Problems Device Displays Incorrect Message (2591); Computer Operating System Problem (2898); Device Operates Differently Than Expected (2913); Improper Device Output (2953)

Patient Problems No Consequences Or Impact To Patient (2199); Low Cardiac Output (2501)

Event Date 08/07/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reported that the computer screen froze on the css console and there was a low cardiac output measurement of 0.9 lpm while supporting a patient.The customer also reported that they tried to reboot the computer, however the patient was switched to the backup css console since the rebooting process was taking too long.The customer also reported that the patient was fine and was exhibiting no symptoms.This alleged failure mode poses a low risk to a patient because the issue 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 is returning to syncardia for evaluation.The results of the investigation will be provided in a supplemental mdr.

Manufacturer Narrative

(b)(4) follow-up report 1.

Event Description

The customer reported that the computer screen froze on the css console and there was a low cardiac output measurement of 0.9 lpm while supporting a patient.The customer also reported that they tried to reboot the computer, however the patient was switched to the backup css console since the rebooting process was taking too long.The customer also reported that the issue resolved when the css console was rebooted.The customer also reported that the patient was fine and was exhibiting no symptoms.The css console computer was not returned to syncardia for investigation due to the customer resolving the issue at the site.A review of the device history record (dhr) confirmed that the css console was serviced and placed into finished goods on 8 may 2015.The console passed all testing performed by production and quality departments and no issues were noted regarding the console computer.This alleged failure mode poses a low risk to a patient because the issue 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.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.

• Brand Name: SYNCARDIA CSS CONSOLE
• Type of Device: EXTERNAL PNEUMATIC DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer (Section G): SYNCARDIA SYSTEMS, INC.; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: carole marcot ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 5012063
• MDR Text Key: 24554190
• Report Number: 3003761017-2015-00256
• 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
• Remedial Action: Replace
• Type of Report: Followup
• Report Date: 08/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CSS CONSOLE
• Device Catalogue Number: 400207
• Device Lot Number: 14
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/11/2015
• 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
• Patient Age: 32 YR