MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA COMPANION 2 DRIVER; EXTERNAL PNEUMATIC DRIVER

Catalog Number 397002-001

Device Problems Device Operates Differently Than Expected (2913); Noise, Audible (3273)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 12/09/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reported that the companion 2 driver exhibited an internal compressor malfunction alarm while supporting a patient at (b)(6).The customer also reported that the patient was subsequently switched to the backup companion 2 driver.There was no reported adverse patient impact.This alleged failure mode poses a low risk to the patient because although the companion 2 driver exhibited a compressor malfunction alarm, it did not prevent the companion 2 driver from performing its life-sustaining functions.The companion 2 driver will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.

Event Description

The customer reported that the companion 2 driver exhibited an internal compressor malfunction alarm while supporting a patient at the (b)(6).The customer also reported that the patient was subsequently switched to the backup companion 2 driver.There was no reported adverse patient impact.The companion 2 driver was returned to syncardia for evaluation.Visual inspection of the driver's external components revealed no anomalies.The patient file was copied and reviewed, which revealed one single compressor malfunction alarm, thus confirming the customer experience.During investigation testing, the single compressor malfunction alarm could not be reproduced.However, further inspection revealed metallic debris around both compressor counterweight assemblies of the left compressor, which indicated that the left compressor was faulty.When the single compressor malfunction alarm occurred during the customer experience, the driver automatically switched to the secondary (right) compressor and continued to provide all necessary life-sustaining functions; therefore, risk to the patient was low.The companion 2 driver is equipped with two compressors, a primary compressor and a secondary compressor.In the event of a primary compressor malfunction, the companion 2 driver will switch to operation on the secondary compressor.The driver was serviced, which included the replacement of the left compressor, before being released to finished goods.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 COMPANION 2 DRIVER
• Type of Device: EXTERNAL PNEUMATIC DRIVER
• Manufacturer (Section D): 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: 5323077
• MDR Text Key: 34925131
• Report Number: 3003761017-2015-00423
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,foreign
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 12/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 397002-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• 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: 49 YR