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

Model Number 595000-001

Device Problems Output Problem (3005); Audible Prompt/Feedback Problem (4020)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/21/2021

Event Type  malfunction  

Manufacturer Narrative

The freedom driver will be returned to syncardia for evaluation.The results will be provided in a follow-up mdr.(b)(4).

Event Description

The freedom driver was not supporting a patient.The customer, a certified syncardia hospital, reported that the freedom driver did not pass the system check out.

Manufacturer Narrative

During investigation testing, the customer-reported low left arterial pressure (lap) was confirmed and replicated.The freedom driver did not pass the functional testing as the lap was outside specifications.The root cause of the customer-reported issue of the freedom driver not passing the system check for low left arterial pressure (lap) was determined to be a malfunction of the piston cylinder assembly.Syncardia has a corrective and preventative action (capa) for the issue of freedom driver elevated left arterial pressure (lap) during testing.Syncardia has completed its investigation and is closing this file.Ce 5684 (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; sanger hall, rm 8-004a; tucson AZ 85713 0454
• Manufacturer (Section G): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: sagar pimpalwar ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 12760527
• MDR Text Key: 281416786
• Report Number: 3003761017-2021-00209
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003121
• UDI-Public: (01)00858000003121
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1