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

Model Number 595000-001

Device Problem Output Problem (3005)

Patient Problems No Consequences Or Impact To Patient (2199); Patient Problem/Medical Problem (2688)

Event Date 10/01/2018

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because although the patient felt differently on the freedom driver, it continued to perform its life-sustaining functions.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 customer, a syncardia certified hospital, reported that the patient indicated feeling more short of breath on exertion and less exercise tolerant since her last freedom driver change out.The customer also reported that the patient felt "somewhat" better after being switched to a backup freedom driver.

Manufacturer Narrative

No alarms were recorded in the driver's alarm history and there were no alarms reported by the customer.The driver passed all sections of functional testing associated with normotensive and hypertensive settings.Additionally, an extended observation run was performed on the driver and it functioned as intended with no high fill volumes or any other abnormalities that would result in the customer-reported issue of the patient feeling short of breath and less exercise tolerant.During investigation testing, the driver performed as intended with 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 and is closing this file.(b)(4) follow-up report 1.

Manufacturer Narrative

Corrected data in h6.(b)(4) follow-up report 2.

• Brand Name: SYNCARDIA FREEDOM DRIVER
• Type of Device: EXTERNAL PNEUMATIC DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• MDR Report Key: 7995424
• MDR Text Key: 124815406
• Report Number: 3003761017-2018-00493
• 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,Followup
• Report Date: 08/30/2019

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: Lay User/Patient
• Device Model Number: 595000-001
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2018
• Initial Date Manufacturer Received: 10/05/2018
• Initial Date FDA Received: 10/23/2018
• Supplement Dates Manufacturer Received: 10/05/2018; 10/05/2018
• Supplement Dates FDA Received: 12/17/2018; 09/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 40 YR