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

Model Number 595000-001

Device Problems Mechanical Problem (1384); Appropriate Term/Code Not Available (3191)

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

Event Date 10/01/2021

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 at the time of the reported event.The customer, a syncardia authorized distributor, reported that the freedom driver dummy battery removes too easily.

Manufacturer Narrative

Corrected data: section b3 to (b)(6) 2021.Section g3 to 10/07/2021.The driver passed all steps of the functional testing which included a test of the locking mechanism for freedom onboard batteries.Additional testing was performed using dummy batteries in an attempt to reproduce the customer-reported issue.During this testing, it was demonstrated that the dummy battery could be removed if it was "wiggled" while pressing the lock button.It was also observed that the width of the dummy batteries is slightly less than the width of the freedom onboard battery.This allows enough space for the dummy battery to be "wiggled" enough to break free of the locking mechanism.This test was reperformed on 5 inventory drivers with their issued dummy batteries with the same results.The customer-reported issue of the dummy battery being removed too easily was confirmed during investigational testing.The root cause could be attributed to the smaller size of the dummy battery when compared to the freedom onboard battery.No evidence of a device malfunction was found during investigation testing.There is no specification that defines the force or effort required to remove the dummy battery from the driver.F-900013-en, freedom driver system operator manual - us, states the following: "the dummy battery should only be removed from the backup freedom driver after inserting an onboard battery when switching the primary freedom driver to the backup freedom driver because of a fault alarm that cannot be resolved." this issue will be tracked and trended as a part of the customer complaint process.Syncardia has completed its investigation 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
• 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: 13014578
• MDR Text Key: 282348732
• Report Number: 3003761017-2021-00241
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003121
• UDI-Public: (01)00858000003121
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• 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
• Date Manufacturer Received: 10/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2017
• 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