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

Model Number 595000-001

Device Problems Noise, Audible (3273); Audible Prompt/Feedback Problem (4020)

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

Event Date 01/14/2021

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 was "a little more noisy than usual" and then exhibited a fault alarm after the patient coughed.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 no abnormalities.Visual inspection of internal components found secondary motor out of primary alignment confirming permanent alarm was due to secondary motor engagement.Freedom driver passed all areas of functional testing for acceptance at incoming inspection without alarm or issue.Additional testing included a valsalva maneuver test in order to mimic the reported coughing episode.Pressure was applied to the pap chamber until the levels were visibly disturbed resulting in resolvable alarm.This test was repeated with the same results.A test of the secondary motor system found no issues or abnormalities.Complaint could not be replicated.Failure investigation for this complaint confirmed the reported issue.Customer complaint was not replicated; root cause of the reported fault alarm after patient's coughing episode was unable to be determined.Failure investigation identified no test failures or damage that could have contributed to the reported complaint.Although unintended secondary motor engagement is a known issue that is currently being investigated, it is not a device malfunction.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 was "a little more noisy than usual" and then exhibited a fault alarm after the patient coughed.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: 11233652
• MDR Text Key: 233722349
• Report Number: 3003761017-2021-00017
• 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: 03/05/2024

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: P/N 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/14/2021
• Initial Date FDA Received: 01/26/2021
• Supplement Dates Manufacturer Received: 01/14/2021
• Supplement Dates FDA Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2018
• 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: 55 YR
• Patient Sex: Male