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

Model Number 397002-001

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/14/2018

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because the reported issue did not prevent the companion 2 driver from performing 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, a syncardia certified hospital, reported that while the patient was being moved to the step-down unit, the companion 2 driver exhibited a sudden drop in cardiac output while supporting the patient.The customer also reported that the patient was switched to a backup companion 2 driver.There was no reported adverse patient impact.

Manufacturer Narrative

The customer-reported drop in cardiac output and "flat" right pressure waveform was confirmed via review of the driver alarm history and logged waveform data.The "flat" right pressure waveform and the drop in cardiac output could not be reproduced during investigation testing.However, during the driver's observation run a slight timing delay manifested in the right flow waveform.The root cause of the drop in cardiac output and "flat" right pressure waveform was determined to be a malfunction of the right pilot valve, which caused a right pressure and flow waveform delay.Over time, these waveform delays likely increased, resulting in a decreased filling time and therefore a decrease in cardiac output.Syncardia has a corrective and preventive action (capa) to for issues related to pilot valve performance.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: 8113015
• MDR Text Key: 129463543
• Report Number: 3003761017-2018-00539
• 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
• Report Date: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2018
• 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: 11/26/2018
• Date Manufacturer Received: 11/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR