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

Model Number 397002-001

Device Problem Use of Device Problem (1670)

Patient Problem Loss of consciousness (2418)

Event Date 07/03/2017

Event Type  Injury  

Manufacturer Narrative

During investigation testing, the driver performed as intended and there was no indication of a device malfunction.The patient data file was reviewed and revealed a shutdown command coinciding with the customer-reported time of the driver stop.The key switch is the only component that will cause a shutdown command to the driver.When the shutdown command is initiated, there is no audible alarm because the driver is acting as intended when the key is turned.The most likely root cause of the customer-reported experience was use error as the key was left in the key switch during patient support.The syncardia companion 2 driver system operator manual, section 6.3 interfaces states: "when the driver is on, the key must be removed from the driver to prevent unintended interruptions to driver operation.Once removed, the key may be stored in a location determined by the clinical staff." 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, a syncardia certified hospital, reported that the companion 2 driver stopped without an alarm while supporting a patient.The customer also reported that the patient became unresponsive.The customer also reported that the patient was switched to a back-up companion 2 driver and recovered.The customer also reported that upon inspection of the companion 2 driver, it was noted that the key was in the switch and turned to the off position.

• 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: michael garippa ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 6737825
• MDR Text Key: 80858012
• Report Number: 3003761017-2017-00128
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003107
• UDI-Public: (01)00858000003107
• 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: Health Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 07/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 397002-001
• Device Catalogue Number: 397002-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR