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

Model Number 397002-001

Device Problems Display or Visual Feedback Problem (1184); Mechanical Problem (1384); Audible Prompt/Feedback Problem (4020)

Patient Problem Loss of consciousness (2418)

Event Date 07/20/2018

Event Type  Injury  

Manufacturer Narrative

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) initial.

Event Description

The customer reported that the patient was supported by the companion 2 driver.The patient was transferred to ct scan and when the patient was back in the ward all was normal.The vad coordinator checked all before leaving after reconnecting the driver to electricity and wall air.The customer also reported that after about 20 minutes, the ward alerted the vad coordinators because of an alarm and they found a low flow alarm (approximately 2.5 l/min).The patient was awake and seemed all right.They tried to give volume but it did not help.After approximately 4 minutes the driver showed zero flow and the patient went unconscious.Pressure waveforms weren't showing full eject or proper ventricle filling.Vad coordinator said it was the same for both sides but is not fully sure because of the emergency situation.The customer also reported that they switched the patient to the backup driver and the patient was immediately better and regained consciousness.The vad coordinator reported that the patient fully recovered to the status before the incident.

Manufacturer Narrative

Ce 4400 follow-up report 2.

Manufacturer Narrative

The customer-reported decrease in cardiac output and abnormal waveform were confirmed via review of the driver alarm history and then reproduced during investigation testing.The root cause of the abnormal waveforms with decreased cardiac output was determined to be malfunctions of the left and right pilot valves, which initially caused both left and right flow waveform delays which were observed during investigation testing.Over time, this flow waveform delay increased, resulting in a decreased filling time and therefore a decrease in cardiac output.Syncardia has a corrective and preventive action (capa) for this issue.Syncardia has completed its evaluation 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: 7757453
• MDR Text Key: 116252147
• Report Number: 3003761017-2018-00424
• 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: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 08/06/2018
• Initial Date Manufacturer Received: 07/20/2018
• Initial Date FDA Received: 08/07/2018
• Supplement Dates Manufacturer Received: 07/20/2018; 07/20/2018
• Supplement Dates FDA Received: 09/04/2018; 10/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 36 YR