MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE; CIRCULATROY ASSIST DEVICE

Model Number CSS CONSOLE

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/28/2014

Event Type  malfunction  

Event Description

The customer reported that the reserve air tank of the css console had a slow air leak and appeared to lose pressure overnight.As a result, he had to exchange air tanks every few days.The customer also reported there was no patient impact and the patient was still being supported by this css console.The patient was subsequently switched to a back driver without adverse impact.The css console was evaluated on site by a syncardia clinical support specialist, who determined that the air leak was the result of a loose fitting on the air line near the reserve tank regulator.The fitting was tightened, and the air leak was resolved.The following day, customer confirmed that the css console performed as intended and there was no evidence of an air leak.

Manufacturer Narrative

This failure mode poses a low risk to a patients, because it would not prevent the css console from performing its life-sustaining functions, since the on-board primary air supply system was not affected the css console has also had a redundant means of supplying air by connecting to hospital wall air.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: CIRCULATROY ASSIST DEVICE
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; tucson AZ
• Manufacturer Contact: carole marcot, esq., vice presid ; 1992 e. silverlake rd.; ce 2018; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 3700861
• MDR Text Key: 21997200
• Report Number: 3003761017-2014-00028
• 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 Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 02/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2014
• 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: 38
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2013
• 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: 39 YR