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

Catalog Number 397002-001

Device Problems Device Operates Differently Than Expected (2913); Output Problem (3005)

Patient Problem Loss of consciousness (2418)

Event Date 10/27/2016

Event Type  Injury  

Manufacturer Narrative

The companion 2 driver will be returned to syncardia for evaluation.The results of the evaluation will be provided in a follow-up mdr.(b)(4).

Event Description

The customer, a syncardia certified hospital, reported that the left cardiac output of the companion 2 driver dropped to zero and the patient became unresponsive.The customer also reported that the patient was switched to the hand pump and intubated.The patient was then switched to a back-up companion 2 driver.All back-up driver parameters were normal, and the patient was subsequently extubated later that same day.

Manufacturer Narrative

The companion 2 driver was returned to syncardia for evaluation.Review of the electronic patient file alarm history revealed numerous very low left cardiac output alarms.Review of the electronic patient data file confirmed the customer-reported issue of a sudden drop in left cardiac output and fill volume.Investigational testing revealed that the left and right pilot valves were not operating properly due to contamination (oil or particulates), most likely from an external air source (hospital air), which restricted the inner component's normal movement.This is the most likely root cause of the customer-reported issue.Syncardia has an open capa (corrective and preventative action) to document the potential root cause and corrective actions associated with this issue.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 left cardiac output of the companion 2 driver dropped to zero and the patient became unresponsive.The customer also reported that the patient was switched to the hand pump and intubated.The patient was then switched to a back-up companion 2 driver.All back-up driver parameters were normal, and the patient was subsequently extubated later that same day.

• 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: 6110387
• MDR Text Key: 60280081
• Report Number: 3003761017-2016-00365
• 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: 10/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2016
• Is this an Adverse Event Report?: Yes
• 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: 11/01/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2011
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 38 YR