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

Catalog Number 595000-001

Device Problems Display or Visual Feedback Problem (1184); Audible Prompt/Feedback Problem (4020)

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

Event Date 04/30/2022

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.

Event Description

The customer, a (b)(6) hospital, reported that the freedom driver exhibited a fault alarm while supporting a patient.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 two new alarms for system current too high and secondary motor voltage too high.These alarms indicate increased resistance on primary motor and secondary motor engagement.Visual inspection of external components found a broken fan cover and a broken rear housing.Visual inspection of internal components found secondary motor out of alignment indicating engagement had occurred.Freedom driver did not pass functional testing as the primary motor seized up.When the secondary motor tried to engage it was unable to do so due to obstruction caused by piston cylinder assembly.A permanent alarm annunciated and no pressure was produced.As a result of this failure a new fault code was recorded in the driver'sdata file reproducing the customer complaint.Additional testing included a functional test with a replacement motor gear-box assembly.Driver passed all sections of functional testing with working motor gear-box.A functional test on the secondary system was also performed with the original motor and obstruction cleared.Driver passed all sections of functional testing pertaining to secondary system and functioned as intended.Failure investigation for this complaint confirmed the reported issue.The customer complaint was replicated during testing; the root cause of the alarm was due to a faulty primary motor that caused binding within the assembly limiting engagement of the secondary motor.Failure investigation found no other test failures or damage that could have contributed to the complaint.Broken fan cover and broken rear housing found during visual inspection are cosmetic due to normal wear and tear and could not have contributed to customer complaint.Freedom driver did not function as designed and binding motors are currently being assessed via capa.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 syncardia certified hospital, reported that the freedom driver exhibited a fault alarm while supporting a patient.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: 14470515
• MDR Text Key: 292474475
• Report Number: 3003761017-2022-00047
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003121
• UDI-Public: (01)00858000003121
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 05/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/26/2017
• 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: 42 YR
• Patient Sex: Male