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

Model Number 595000-001

Device Problems Break (1069); Audible Prompt/Feedback Problem (4020)

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

Event Date 06/24/2021

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 lying in bed.There was no reported adverse patient impact.The customer also reported that the patient was switched to a backup driver.

Event Description

The customer, a syncardia certified hospital, reported that the freedom driver exhibited a fault alarm while supporting the patient lying in bed.There was no reported adverse patient impact.The customer also reported that the patient was 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 primary motor timeout after not engaging for more than five seconds after a continuous open or short detected.Visual inspection of external components found a chip and crack on fan cover.Visual inspection of internal components found bottom right anchor boss pin-nut is protruding.Also, the black cable of the primary motor sensor for alignment is damaged and out of the port connector.Freedom driver failed functional testing for acceptance at incoming inspection due to driver alarm upon initial start up.The damaged black cable of the sensor was conclusively determined to be the root cause of the reported issue and subsequent testing failure.Piston cylinder assembly would not be able to operate as intended and an alarm should annunciate as an indication of the inoperability.Failure investigation for this complaint confirmed the reported issue.The customer complaint was replicated during testing; root cause of the reported unresolvable fault alarm was determined to be a damaged piston and cylinder assembly, specifically, a damaged black cable of the sensor that was pulled from port connector.Failure investigation identified no other test failures or damage that could have contributed to the complaint.Damage found to the fan cover and bottom right anchor boss pin-nut is cosmetic only.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.

• 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: 12162790
• MDR Text Key: 261552580
• Report Number: 3003761017-2021-00135
• 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: 03/25/2024

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: Lay User/Patient
• 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: 06/24/2021
• Initial Date FDA Received: 07/13/2021
• Supplement Dates Manufacturer Received: 06/24/2021
• Supplement Dates FDA Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2018
• 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: 30 YR
• Patient Sex: Male