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

Model Number 595000-001

Device Problems Appropriate Term/Code Not Available (3191); Audible Prompt/Feedback Problem (4020)

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

Event Date 10/28/2021

Event Type  malfunction  

Event Description

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

Manufacturer Narrative

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

Manufacturer Narrative

The customer reported that the freedom driver did not pass the system check due to a fault alarm when the batteries were inserted.Visual inspection did not reveal any abnormalities.The driver's alarm history was reviewed and revealed four 2d alarm codes.This alarm code is recorded when there is unexpected operation of the secondary motor.This can occur when the secondary motor is out of alignment while the primary motor attempts to operate.Since there were four 2d fault alarms, it is likely that they were all produced during the battery insertions by the customer with the secondary motor was out of alignment.The driver passed all functional testing on both the primary and secondary motors, including an extended observation run and a battery exchange test.The customer-reported fault alarm could not be reproduced during testing.The driver functioned as intended and there was no evidence of a device malfunction.This issue will be monitored and trended as part of the customer complaint process.Syncardia has completed its investigation and is closing this file.Ce 5688 comp(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: kerri hensley ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 12771394
• MDR Text Key: 281417430
• Report Number: 3003761017-2021-00213
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 06/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• 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: 10/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2017
• 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