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

Catalog Number 397002-001

Device Problems No Display/Image (1183); Device Displays Incorrect Message (2591)

Patient Problem Pallor (2468)

Event Date 05/16/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reported that the companion 2 driver, which was supporting a patient and was docked in a companion driver caddy, exhibited an alarm.The customer also reported that the display screen was white.The customer reported that the patient was switched to the backup companion 2 driver.The customer also reported that the patient appeared pale but did not lose consciousness during the switch to the backup driver.This alleged failure mode poses a low risk to the patient because it did not prevent the companion 2 driver from performing its life-sustaining functions.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

The companion 2 driver was returned to syncardia for evaluation.During investigation testing, the customer-reported issue was confirmed.This issue has been previously investigated which identified the root cause as a malfunction of the main printed circuit assembly (pca).After the originally installed main pca was replaced with a properly functioning test unit, the companion 2 driver functioned as intended which confirmed that the root cause of the customer reported display issue was a malfunctioning main pca.This alleged failure mode poses a low risk to the patient because it did not prevent the companion 2 driver from performing its life-sustaining functions.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.(b)(4).

Event Description

The customer reported that the companion 2 driver, which was supporting a patient and was docked in a companion driver caddy, exhibited an alarm.The customer also reported that the display screen was white.The customer reported that the patient was switched to the backup companion 2 driver.The customer also reported that the patient appeared pale but did not lose consciousness during the switch to the backup driver.

• Brand Name: SYNCARDIA COMPANION 2 DRIVER
• Type of Device: EXTERNAL PNEUMATIC DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: carole marcot ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 5683699
• MDR Text Key: 46313964
• Report Number: 3003761017-2016-00217
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 05/16/2016

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: 05/24/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/16/2016
• Initial Date FDA Received: 05/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2011
• 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
• Patient Age: 39 YR