MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM DRIVER; EXTERMAL PNEUMATIC DRIVER

Model Number 595000-001

Device Problem Audible Prompt/Feedback Problem (4020)

Patient Problem No Patient Involvement (2645)

Event Date 11/14/2018

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because the issue was observed while the driver was not supporting a patient.The freedom 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 freedom driver was not supporting a patient.The customer, a syncardia certified hospital, reported that the freedom driver exhibited a fault alarm as soon as it was turned on.

Manufacturer Narrative

The customer-reported issue, a fault alarm upon startup, was confirmed via the alarm code 18 in the driver's alarm history.This alarm is produced with a malfunction of the u31 pressure sensor on the main printed circuit board assembly (pcba).During investigational testing, the fault alarm was reproduced.The root cause was determined to be a malfunction of the u31 pressure sensor on the main pcba.Despite the alarm, the driver passed all pressure and cardiac output requirements of functional testing.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation and is closing this file.Ce 4571 follow-up report 1.

• Brand Name: SYNCARDIA FREEDOM DRIVER
• Type of Device: EXTERMAL PNEUMATIC DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• MDR Report Key: 8113021
• MDR Text Key: 129455574
• Report Number: 3003761017-2018-00537
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003121
• UDI-Public: (01)00858000003121
• 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: 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 595000-001
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2018
• Initial Date Manufacturer Received: 11/14/2018
• Initial Date FDA Received: 11/28/2018
• Supplement Dates Manufacturer Received: 11/14/2018
• Supplement Dates FDA Received: 02/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1