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

Catalog Number 595000-001

Device Problem Noise, Audible (3273)

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

Event Date 10/31/2022

Event Type  malfunction  

Event Description

Patient 187-ae at enk duisburg had a freedom exchange earlier than planned due to a strange sound the freedom s/n (b)(4) was producing.Freedom driver s/n (b)(4) (one of the backups) is now the active device.Patient and hospital staff experienced an intermittent feathering noise.To be on the safe side they replaced the freedom driver (s/n (b)(4) with one of the backup devices.Freedom driver s/n (b)(4) active since (b)(6) 2022.Clarification on 'feathering' noise requested.Distributor response, 'a 20 to 30 second high frequency constant tone so not related to the heartbeat.'.

Manufacturer Narrative

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

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 no new alarms recorded in the driver's data file.Visual inspection of external components found no abnormalities.Visual inspection of internal components found black, sooty dust on top of pca and motors, seemingly sourced from the primary motor as there is no indication of secondary motor engagement.The primary side yoke dowel is extruded slightly, which would not prevent normal operation of the driver.Scuff marks noted on the main pcb and pca indicated contact between the two components.Debris was found accumulated in the top and bottom of the front cover.The bottom left anchor boss of the front housing was cracked.A melt mark was found on the ribbon cable from speaker to lcd.Both motors were found to turn by hand without binding or issue.Freedom driver passed all areas of functional testing for incoming inspection, however, there was a high pitched, low volume "chirping" sound identified that corresponded with the driver's pumping action.The sound ceased after fourteen minutes of operation and did not restart.The driver was placed on an extended observation run.The sound did not reoccur and functioned within normal parameters throughout testing.No alarms were produced and both motors were found to spin freely throughout testing.It is unclear if the technician reported "chirping" sound and the customer reported "feathering" sound are the same, however, an unknown noise was confirmed.Failure investigation for this complaint confirmed the reported issue.A nonspecific sound was identified during testing, therefore, the customer complaint is considered to have been replicated; root cause of the unknown sound, however, could not be determined.Failure investigation identified no test failures or damage that could have contributed to the customer complaint.Debris and damage found internally in the driver was cosmetic but was not conclusively attributed to the unknown sound produced by the driver.These observations were considered cosmetic only and likely due to normal wear and tear.Motors were found to function normally and no evidence of binding or 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

Patient (b)(6) at enk duisburg had a freedom exchange earlier than planned due to a strange sound the freedom s/n (b)(6) was producing.Freedom driver s/n (b)(6) (one of the backups) is now the active device.Patient and hospital staff experienced an intermittent feathering noise.To be on the safe side they replaced the freedom driver (s/n (b)(6) with one of the backup devices.Freedom driver s/n (b)(6) active since (b)(6) 2022.Clarification on 'feathering' noise requested.Distributor response, 'a 20 to 30 second high frequency constant tone so not related to the heartbeat.'.

• 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: 15801361
• MDR Text Key: 304967132
• Report Number: 3003761017-2022-00127
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2017
• 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: 58 YR
• Patient Sex: Female