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

Catalog Number 397002-001

Device Problems Loss of Power (1475); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/15/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reported that the companion 2 driver compressors were cycling on and off.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's compressor was cycling on and off, it did not prevent the driver from performing its life-sustaining functions.The companion 2 driver will be returned to syncardia for investigation.The results of the investigation will be provided in a follow-up mdr.

Manufacturer Narrative

(b)(4).

Event Description

The customer reported that the companion 2 driver compressors were cycling on and off.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 investigation.The patient file was reviewed and revealed numerous external air connected notifications.This is an indication that the necessary conditions required for the driver to operate exclusively on external air were not consistently met, thereby causing the driver to disable the external air connected icon and activate the primary compressor.This confirmed the customer-reported compressor cycling issue.The failure investigation confirmed that the manual pressure regulator could not maintain the proper set point; therefore, the manual pressure regulator was taken out of service and replaced.The root cause for this failure mode is most likely the inability of the manual pressure regulatory to maintain proper set point.The issue of compressor cycling because of a malfunction of the manual pressure regulator is being investigated in a capa (corrective or preventive action).The capa will document the investigation including, but not limited to, potential root cause and corrective actions associated with compressor cycling because of a malfunction of the manual pressure regulator.The companion 2 driver was serviced and passed all functional and performance testing before being placed into finished goods.Although the compressors were cycling on and off, the risk to the patient would have been low because the driver continued to perform its life-sustaining functions.Additionally, centers are equipped with backup drivers.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: 5749102
• MDR Text Key: 48928778
• Report Number: 3003761017-2016-00244
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003107
• UDI-Public: (01)00858000003107
• 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: Replace
• Type of Report: Initial,Followup
• Report Date: 06/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 397002-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2012
• 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