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

Catalog Number 397002-001

Device Problems No Display/Image (1183); Computer Operating System Problem (2898)

Patient Problem No Patient Involvement (2645)

Event Date 04/25/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

This (b)(4) was not supporting a patient.The customer reported that when he switched on the (b)(4), it did not boot up, it started pumping immediately and showed a computer firmware screen with setup from the main board.The customer also reported that the driver could not be switched off, and the driver continued to pump until the internal emergency battery depleted.This alleged failure mode poses a low risk to a patient because the issue was observed when the (b)(4) was not supporting a patient.The (b)(4) 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

This companion 2 driver was not supporting a patient.The customer reported that when he switched on the companion 2 driver, it did not boot up, it started pumping immediately and showed a computer firmware screen with setup from the main board.The customer also reported that the driver could not be switched off, and the driver continued to pump until the internal emergency battery depleted.The companion 2 driver was returned to syncardia for evaluation.Visual inspection of the driver's external and internal components revealed no anomalies.During failure investigation testing, the boot up issue, as observed by the customer, was reproduced.It was determined that the 3-volt battery installed on the main board printed circuit assembly (pca) was depleted.The normal service cycle for the 3-volt battery is every two calendar years.Since the 3-volt battery was depleted after 79 days of driver use, it is possible that there was an issue with the main board pca that led to the premature depletion.As a result, both the 3-volt battery and the main board pca were replaced.The driver was serviced before being released to finished goods.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.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: 5626145
• MDR Text Key: 44805696
• Report Number: 3003761017-2016-00181
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2016
• 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: 05/02/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/31/2012
• 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