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); Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2019

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses low risk to the patient because the reported issue did not prevent the driver from performing its life sustaining functions.The companion 2 driver has been returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4).

Event Description

The customer, a syncardia certified hospital, reported that the companion 2 driver displayed an irregular waveform and there was decreased cardiac output while supporting a patient.There was no reported adverse patient impact.The customer also reported that the patient was subsequently switched to a backup driver.

Manufacturer Narrative

The customer-reported incorrect right flow waveform and decrease in cardiac output and fill volumes were reproduced during investigation testing, where the right flow waveform displayed a timing delay (decreased time in diastole).The root cause was determined to be a malfunction of the right pilot valve.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: 9197560
• MDR Text Key: 162550306
• Report Number: 3003761017-2019-00298
• 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: 11/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2019
• 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: 379002-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2019
• Date Manufacturer Received: 10/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 35 YR