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

Model Number CSS CONSOLE

Device Problems Mechanical Problem (1384); Failure to Power Up (1476); Visual Prompts will not Clear (2281); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 11/16/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The css console was not supporting a patient.The customer reported that the vacuum in css console would not turn on.The customer also reported that the reserve tank low pressure indicator did not turn off despite the console having a 3500 pounds per square inch (psi) tank installed.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

(b)(4).

Event Description

The css console was not supporting a patient.The customer reported that the vacuum in the css console would not turn on.The customer also reported that the reserve tank low pressure indicator did not turn off despite the console having a 3500 pounds per square inch (psi) air tank installed.The css console was returned to syncardia for evaluation.Visual inspection of the external components revealed no anomalies.During investigation testing, the vacuum potentiometer behind the alarm panel was observed to be broken.The broken potentiometer prevented the vacuum from responding when the vacuum setting was adjusted.The vacuum potentiometer was replaced.The reserve tank low pressure light functioned as intended.The root cause for the reported issue of the light not turning off was likely the result of its set point being set to the upper limit of the specified range, which caused the deactivation set point to be above 3500 psi.After the alarm set point was adjusted to 2800 psi, the light functioned as intended.There was no evidence of a malfunction of the reserve tank low pressure light.After repairs and adjustments, the css console passed all final performance testing.This 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 has a redundant, backup controller.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: 5242746
• MDR Text Key: 32143344
• Report Number: 3003761017-2015-00400
• 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: 11/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2015
• 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: 1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2014
• 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