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

Catalog Number P/N 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 03/20/2023

Event Type  malfunction  

Event Description

The customer, a syncardia certified hospital, reported that the driver alarmed when placed on the patient.The patient was switched to a back-up driver.The customer also reported "that there was no negative impact to the patient with regard to the tah support.".

Manufacturer Narrative

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

Manufacturer Narrative

Alarm history review found one new alarm recorded, a "28" fault code indicating "lcd regulator 1 too low", which is produced when a change in voltage is detected during operation of the unit.Visual inspection of internal components and external components revealed no damage or abnormalities.Driver passed all incoming functional testing.Additional testing was performed to replicate the alarm fault code 28, "lcd regulator 1 too low" by performing a driver power cycle test.Test freedom batteries were alternately exchanged and the driver was cycled after each change for a total of ten cycles.Testing was not able to replicate the condition and no fault alarms occurred during the test.Failure investigation for this complaint confirmed the reported issue via alarm history data review.No unintended alarms occurred during incoming testing.The complaint was not replicated via observational testing.The root cause of the customer reported alarm was unable to be determined.Failure investigation identified no test failure, damage, or abnormalities, driver functioned as intended.Customer reported no negative impact to the patient with regard to the the tah support and driver exchange reported under this complaint.This issue will be monitored and trended as part of the customer complaint process.Syncardia has completed its evaluation and is closing this file.(if new or additional information is received in the future, syncardia will file a follow-up mdr.) (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: aaron meier ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 16744581
• MDR Text Key: 313428541
• Report Number: 3003761017-2023-00054
• Device Sequence Number: 1
• Product Code: LOZ
• 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: 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: P/N 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• 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
• Patient Age: 22 YR
• Patient Sex: Male