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

Catalog Number 397002-001

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 09/23/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The companion 2 driver was not supporting a patient.The customer reported that the companion 2 driver continued to exhibit single compressor malfunction alarms during the system check.This alleged failure mode poses a low risk to a patient because the issue was observed when the companion 2 driver was not supporting a patient.The companion 2 driver will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.

Manufacturer Narrative

(b)(4).Follow-up report 1.

Event Description

The companion 2 driver was not supporting a patient.The customer reported that the companion 2 driver continued to exhibit single compressor malfunction alarms during the system check.The companion 2 driver was returned to syncardia for evaluation.The patient file was copied and reviewed, which revealing three single compressor malfunction alarms that occurred on (b)(6) 2015.These single compressor malfunction alarms occurred after completing the system check test while in single pulse mode without drivelines connected.The customer-reported issue was confirmed.During investigation testing, efforts to reproduce the customer-reported single compressor malfunction alarms were successful.The root cause was a malfunction of the left compressor.The left compressor was taken out of service and replaced.The issues with single compressor malfunction alarms from occurring when the driver is running without drivelines are 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.This failure mode poses a low risk to a patient because the companion 2 driver was not supporting a patient when the single compressor malfunction alarms occurred.In addition, the driver would have continued to perform its life-sustaining functions.The companion 2 driver was serviced and passed all functional and performance testing before being placed into 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: 5127697
• MDR Text Key: 27850721
• Report Number: 3003761017-2015-00321
• 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: Followup
• Report Date: 09/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 10/01/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/05/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/23/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/19/2015
• 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