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 Patient Involvement (2645); No Code Available (3191)

Event Date 03/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4) initial.

Event Description

The companion 2 driver was not supporting a patient.The customer reported that the companion 2 driver failed 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 evaluation will be provided in a follow-up mdr.

Manufacturer Narrative

(b)(4).

Event Description

The companion 2 driver was not supporting a patient.The customer reported that the companion 2 driver failed the system check.The companion 2 driver was returned to syncardia for evaluation.Visual inspection of the driver's external and internal components revealed no anomalies.The patient file was copied and reviewed, which revealed two system check failures confirming the customer experience.During investigation testing, the customer-reported issue was reproduced.The root cause of the customer-reported system check failure was a faulty transducer (m10) on the pressure sensor printed circuit assembly (pca).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.Per syncardia's companion 2 driver system operator manual - english us, section 18, hospital personnel are instructed to complete the companion 2 driver system check upon receipt, prior to use, and every six months if the driver is not in use.The system check verifies that the driver can operate and function as intended.The driver was serviced, which included the replacement of the pressure sensor board, before being released to finished goods.After replacement of the pressure sensor pca, the driver met all test performance requirements.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: 5498606
• MDR Text Key: 40562081
• Report Number: 3003761017-2016-00082
• 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: 03/01/2016

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: 04/06/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2016
• Initial Date FDA Received: 03/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2015
• 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