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

Model Number 397002-001

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2018

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because the driver continued to perform its life-sustaining functions.The companion 2 driver measures air to provide an estimate of the blood flow in the form of a fill volume number.Tee (transesophageal echocardiography) measures the actual blood flow.The companion 2 driver has been returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.Ce (b)(4) initial.

Event Description

The customer, a syncardia certified hospital, reported that the companion 2 driver's fill volumes were not coinciding with tee (transesophageal echocardiography) while supporting a patient.The customer also reported that the patient was subsequently switched to a backup driver and there was no reported adverse patient impact.

Manufacturer Narrative

The driver passed all sections of functional testing.Additionally, an extended observation run was performed on the driver and it performed as intended with no alarms or issues in relation to the fill volumes that would indicate a device malfunction.The customer did not report any data from the tee (transesophageal echocardiography) to be compared against the driver.The patient file review showed 11 instances of fill volume high alarms, however these are more a representation of the patient condition at the time of the alarms and not indicative of a device malfunction.The companion 2 driver system operator manual (c2-900005) has the following corrective action for left fill volume high alarms: verify driver settings are achieving full eject/partial fill conditions from driver displayed wave forms, assess patient conditions that may contribute to a left fill volume high alarm.If alarm persists, certified clinical staff may make adjustment to device.The driver performed as intended and there was no evidence of a device malfunction.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.

• 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
• MDR Report Key: 7965915
• MDR Text Key: 123806339
• Report Number: 3003761017-2018-00483
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003107
• UDI-Public: (01)00858000003107
• Combination Product (y/n): N
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 10/03/2018
• Date Manufacturer Received: 10/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR