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

Catalog Number 397002-001

Device Problems Failure to Cycle (1142); Device Operational Issue (2914)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 12/08/2016

Event Type  malfunction  

Manufacturer Narrative

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 has been 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 companion 2 driver compressors cycled on and off while the driver was connected to wall air and supporting a patient.There was no reported adverse patient impact.

Manufacturer Narrative

The companion 2 driver was returned to syncardia for evaluation.Review of the electronic patient data file revealed multiple external air connected notifications.This is an indication that the necessary conditions required for the driver to operate exclusively on external air were not consistently met, thereby causing the driver to disable the external air connected icon and activate the primary compressor.This confirmed the customer-reported issue.Investigational testing was performed to reproduce the "compressor cycling" as observed by the customer.During the observation run, intermittent compressor cycling did occur, thus reproducing the customer experience.A malfunction of the manual pressure regulator to maintain the required pressure set point value was identified as the root cause.This caused intermittent compressor cycling while the driver was connected to wall air.Syncardia has an open capa (corrective and preventive action) which will document the investigation including, but not limited to, potential root cause and corrective actions associated with compressor cycling because of a malfunction of the manual pressure regulator.Syncardia has completed its evaluation of this complaint and is closing this file.(b)(4) follow-up report 1.

Event Description

The customer, a syncardia certified hospital, reported that the companion 2 driver compressors cycled on and off while the driver was connected to wall air and supporting a patient.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: 6221938
• MDR Text Key: 64191968
• Report Number: 3003761017-2016-00412
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 0858000003107
• UDI-Public: (01)0858000003107
• 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: 12/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2017
• 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: 12/20/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2012
• 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
• Patient Age: 23 YR