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

Model Number CSS CONSOLE

Device Problems Failure to Charge (1085); Failure to Power Up (1476)

Patient Problem No Code Available (3191)

Event Date 11/18/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The css console was not supporting a patient.The customer reported that the alarm panel in the css console is not charging despite being plugged in overnight.The customer also reported that the css console vacuum will not turn on.The customer also reported the left pressure waveforms and left cardiac output (co) will not display on the css console computer screen.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 and its operating system are used solely as a monitoring device and do not control the functionality of the css console.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

(b)(4).

Event Description

This css console was not supporting a patient.The customer reported that the alarm panel battery in the css console was not charging despite the css console being plugged in overnight.The customer also reported that the css console vacuum did not turn on.The customer also reported the left pressure waveforms and left cardiac output (co) did not display on the css console computer screen.The css console was returned to syncardia for evaluation.Visual inspection of the css console batteries did not reveal any anomalies.No signs of corrosion or improper installation were observed.The css console battery sense circuitry wires were inspected and no abnormalities were observed.The css console was functionally tested and did not meet the test acceptance criteria for electrical power to operate it.The root cause for the reported issue was a malfunction of the backup power supply/battery charger.The backup power supply/battery charger was replaced, and the css console passed all final performance testing and performed as intended.This failure mode posed 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 has redundant controllers with their own internal backup batteries and power supplies that will continue to perform their life-sustaining functions even with the failure of the css console's power supply.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 CIRCULATORY SUPPORT SYSTEM CONSOLE
• Type of Device: EXTERNAL PNEUMATIC DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; 1992 e. silverlake rd.; tucson AZ 85713
• Manufacturer Contact: carole marcot ; 1992 e. silverlake rd.; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 5250780
• MDR Text Key: 32244343
• Report Number: 3003761017-2015-00406
• 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: Repair
• Type of Report: Initial,Followup
• Report Date: 11/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2015
• 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: 37
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/27/2006
• 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 Outcome(s): Disability