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

Catalog Number 397002-001

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 12/09/2015

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 did not pass 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).

Event Description

The companion 2 driver was not supporting a patient.The customer reported that the companion 2 driver did not pass the system check.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, revealing the system check failure as observed by the customer.During investigation testing, the right vacuum blower was capable of operating within required parameters, and the customer-reported system check failure could not be duplicated.The driver performed as intended during investigation testing, and there was no evidence of a device malfunction.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 driver was serviced, which included the right vacuum blower being replaced as a precautionary measure and the replacement of the power management board (pmb), 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.

Manufacturer Narrative

(b)(4).Please note that this is a corrected report.The patient file was copied and reviewed, revealing the system check failure as observed by the customer.The system check failure was the result of the right vacuum performing one (1) mmhg beyond the defined maximum limit for the companion 2 driver.

Event Description

The companion 2 driver was not supporting a patient.The customer reported that the companion 2 driver did not pass the system check.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, revealing the system check failure as observed by the customer.The system check failure was the result of the right vacuum performing one (1) mmhg beyond the defined maximum limit for the companion 2 driver.During investigation testing, the right vacuum blower was capable of operating within required parameters, and the customer-reported system check failure could not be duplicated.The driver performed as intended during investigation testing, and there was no evidence of a device malfunction.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 driver was serviced, which included the right vacuum blower being replaced as a precautionary measure and the replacement of the power management board (pmb), 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: 5323100
• MDR Text Key: 34925900
• Report Number: 3003761017-2015-00424
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,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: Health Professional
• Device Catalogue Number: 397002-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2015
• 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