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 12/10/2019

Event Type  malfunction  

Manufacturer Narrative

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 authorized warehouse, reported that during testing of the freedom driver, cardiac output and fill volume displayed were inaccurate.

Manufacturer Narrative

The driver passed all sections of functional testing.Additionally, an extended observation run was performed on the driver.No abnormalities were observed during this test and the driver's cardiac output was within 10% of the donovan mock tank's cardiac output.During investigation testing, the customer-reported issue was not reproduced and there was 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.Ce 5113 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: 9548903
• MDR Text Key: 174684854
• Report Number: 3003761017-2020-00004
• 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: foreign,other
• Type of Report: Initial,Followup
• Report Date: 01/13/2020

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: Other
• Device Model Number: 595000-001
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Initial Date Manufacturer Received: 12/10/2019
• Initial Date FDA Received: 01/03/2020
• Supplement Dates Manufacturer Received: 12/10/2019
• Supplement Dates FDA Received: 01/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1