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

Model Number CSS CONSOLE

Device Problem Calibration Problem (2890)

Patient Problems No Patient Involvement (2645); No Information (3190)

Event Date 10/14/2016

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.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) initial.

Event Description

This css console was not supporting a patient.The customer reported that he could not get the css console to calibrate.

Manufacturer Narrative

The css console was returned to syncardia for evaluation.The customer-reported unsuccessful calibration was confirmed.The root cause was determined to be that the printed circuit assembly (pca) drifted beyond the scope of calibration that can be performed by the hospital staff.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 he could not get the css console to calibrate.

• 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: 6063816
• MDR Text Key: 59023964
• Report Number: 3003761017-2016-00364
• 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: 10/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2016
• 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: 37
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2015
• 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