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); Battery Problem (2885)

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

Event Date 12/07/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The companion 2 driver was not supporting a patient.The customer reported that there was a red emergency battery indictor displayed when the companion 2 driver was plugged into the main power.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 there was a red emergency battery indictor displayed when the companion 2 driver was plugged into the main power.The companion 2 driver s/n (b)(4) was returned to syncardia for evaluation.The patient file was copied and reviewed, revealing an emergency battery error alarm.The customer-reported issue was confirmed.During investigation testing, efforts to reproduce the emergency battery error alarm were successful.The emergency battery's system management bus (smbus) data was retrieved and reviewed to determine the battery's operational, permanent fault, and history event status.Review of the data revealed that the root cause of the customer-reported emergency battery error alarm was that the emergency battery had a permanent fault with a trigger value of 0400, which is an over-current charging fault.It is unknown what caused the over-current charging fault, and this is an isolated event.The driver was not in patient use at the time of the emergency battery error alarm.If the driver was in patient use at the time of the customer experience, this failure mode would pose a low risk to the patient because the driver would continue to perform its life-sustaining functions.The emergency battery is one of four redundant power sources and is designed to be used only in the event that ac power and the two external batteries have either been depleted or removed from the driver.The emergency battery was taken out of service.After replacement of the emergency battery, the driver performed as intended, passing all performance requirements.The driver was serviced, 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: 5289533
• MDR Text Key: 33894694
• Report Number: 3003761017-2015-00421
• 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: 12/07/2015

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: 12/14/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2015
• Initial Date FDA Received: 12/11/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2012
• 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