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

Model Number 595000-001

Device Problem Output Problem (3005)

Patient Problem No Patient Involvement (2645)

Event Date 09/18/2019

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to a patient because the issue was observed when the freedom driver was not supporting a patient.The freedom driver will be 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 did not pass system check out procedure because the cardiac output reading was low and the display showed asterisks.

Manufacturer Narrative

The driver in "as received" condition passed all sections of functional testing.Additionally, an extended observation run was performed with a donovan mock tank where right arterial pressure (rap) values were gradually decreased to reduce the cardiac output (co) in an attempt to recreate the customer-reported issue.As expected, co values decreased to less than 4.9 l/min, but they did not decrease to 2.1 l/min as was observed by the customer.The driver also did not display any asterisks during these tests.The customer-reported issue could not be confirmed or reproduced.The driver performed as intended with no evidence of a device malfunction.The root cause of the customer-reported issue could not be conclusively determined.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation of this complaint and is closing this file.(b)(4) follow-up report 1.

• 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: 9141517
• MDR Text Key: 161041382
• Report Number: 3003761017-2019-00290
• 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: 11/11/2019

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: 09/24/2019
• Initial Date Manufacturer Received: 09/18/2019
• Initial Date FDA Received: 10/01/2019
• Supplement Dates Manufacturer Received: 09/18/2019
• Supplement Dates FDA Received: 11/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1