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

Catalog Number 397002-001

Device Problems Display or Visual Feedback Problem (1184); Device Operates Differently Than Expected (2913); Improper Device Output (2953)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/22/2016

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because although the companion 2 driver exhibited a discrepancy between the left and right cardiac outputs, the companion 2 driver continued to perform its life-sustaining functions.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 reported that the companion 2 driver exhibited a display discrepancy between the left and right cardiac output.The customer also reported that the green indication bars on the cardiac output curve indicated the correct position of the inflow into the device.The patient was subsequently switched to the backup companion 2 driver.There was no reported adverse patient impact.

Manufacturer Narrative

The companion 2 driver was returned to syncardia for evaluation.The customer-reported cardiac output (co) discrepancy was confirmed via review of the patient data file, but was not able to be reproduced during investigation testing.The driver passed all functional testing and was subjected to an additional observation run in an attempt to reproduce the cardiac output discrepancy.The largest co discrepancy observed during the investigation was within syncardia's co specification.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) follow-up report 1.

Event Description

The customer reported that the companion 2 driver exhibited a display discrepancy between the left and right cardiac output.The customer also reported that the green indication bars on the cardiac output curve indicated the correct position of the inflow into the device.The patient was subsequently switched to the backup companion 2 driver.There was no reported adverse patient impact.

• 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: 5993571
• MDR Text Key: 56804853
• Report Number: 3003761017-2016-00331
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 0858000003107
• UDI-Public: (01)0858000003107
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 09/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2016
• 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: 10/19/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2015
• 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 Age: 47 YR