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

Model Number 595000-001

Device Problem Audible Prompt/Feedback Problem (4020)

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

Event Date 11/29/2021

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 customer, a syncardia certified hospital, reported that the freedom driver exhibited a fault alarm while supporting the patient.The driver beat rate changed from 130 bpm to 125 bpm.The patient and staff deny any event increasing his intrathoracic pressure, (i.E.Coughing, sneezing, blowing nose, having bm, etc.).There was no reported adverse patient impact.The customer also reported that the patient was subsequently switched to a backup driver.

Manufacturer Narrative

Device history record (dhr) review confirmed that freedom driver s/n (b)(6) was serviced and passed all functional testing prior to being released to finished goods.Alarm history and patient data file review found one new alarm indicating secondary motor voltage too high.Visual inspection of external components found display and exhaust fan covers cracked as well as some wear on the labeling.Visual inspection of internal components found secondary motor out of primary alignment confirming the recorded alarm was due to secondary motor engagement.Cracks found on multiple front housing anchor bosses.Main board found with multiple scuff marks indicating contact with primary motor and piston cylinder assembly accompanied by silver dust in the lower right section of the main board.A melt mark was also found on the ribbon cable connecting the speaker to lcd near bend by the primary motor.Freedom driver failed functional testing for acceptance at incoming inspection due to out of specification cardiac output.A 48-hour observation run was performed without issue or alarm.The secondary motor system was also tested due to evidence of secondary motor engagement.Driver passed all areas of functional testing.Primary and secondary motors were also spun by hand and were found to be spinning freely.Complaint could not be replicated.Failure investigation for this complaint confirmed the reported issue from alarm history review.The customer complaint was not replicated as no alarms were produced during functional testing; root cause of the reported fault alarm was unable to be determined.Failure investigation found no other test failures or damage that could have contributed to the complaint.External damage found was cosmetic due to normal wear.No evidence of a device malfunction was found.Patient was switched to a backup driver without any reported adverse impact.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.

Event Description

The customer, a (b)(6) hospital, reported that the freedom driver exhibited a fault alarm while supporting the patient.The driver beat rate changed from 130 bpm to 125 bpm.The patient and staff deny any event increasing his intrathoracic pressure, (i.E.Coughing, sneezing, blowing nose, having bm, etc.).There was no reported adverse patient impact.The customer also reported that the patient was subsequently switched to a backup driver.

• 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: 12935127
• MDR Text Key: 284354764
• Report Number: 3003761017-2021-00232
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/06/2024

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: 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
• Initial Date Manufacturer Received: 11/29/2021
• Initial Date FDA Received: 12/06/2021
• Supplement Dates Manufacturer Received: 11/29/2021
• Supplement Dates FDA Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2017
• 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
• Patient Age: 22 YR
• Patient Sex: Male