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

Catalog Number 595000-001

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 05/05/2022

Event Type  malfunction  

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

The freedom driver will be returned to (b)(6) 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 five new alarms indicating secondary motor engagement recorded in the driver's data file.Multiple alarms regarding the secondary motor indicate the primary motor struck the secondary motor multiple times.Visual inspection of external components found no abnormalities.Visual inspection of the internal components found the secondary motor was not in the default position.Freedom driver passed all functional testing for acceptance at incoming inspection.Additional testing was performed in an attempt to replicate the customer reported fault alarm.A functional test was performed on the secondary system reproducing the intended alarm when secondary motor is engaged, however, no pressure changes or abnormalities were observed.Failure investigation for this complaint could not confirm the cause of the reported issue.Although testing the secondary system resulted in an alarm, this is an intended alarm to mitigate harm and give patients an alert to switch drivers.The root cause of the unintended secondary motor engagement was unable to be determined with this data.Failure investigation identified no test failures or damage that could have contributed to the complaint.Freedom driver functioned as designed.Patient was switched to a backup driver without any reported adverse impact.

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: 14470523
• MDR Text Key: 292571250
• Report Number: 3003761017-2022-00048
• 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: 10/12/2023

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 Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 05/09/2022
• Initial Date FDA Received: 05/23/2022
• Supplement Dates Manufacturer Received: 05/09/2022
• Supplement Dates FDA Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2018
• 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: 42 YR
• Patient Sex: Male