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

Catalog Number 595000-001

Device Problem Mechanical Problem (1384)

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

Event Date 12/13/2022

Event Type  malfunction  

Manufacturer Narrative

The freedom driver will be evaluated.The results will be provided in a follow-up mdr.

Event Description

The syncardia service technician reported that the freedom driver had a primary motor that was stuck was not able to complete as received functional testing.

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 a malfunction of the primary motor.Visual inspection of external components found damage to the exhaust fan cover.Visual inspection of internal components found secondary motor out of alignment and an issue with the primary motor shell spinning but the cam follower not moving with it.Freedom driver failed functional testing during investigation.Although the driver produced a dragging noise, no pressure was produced eventually causing an alarm to annunciate and the secondary motor to engage.Testing continued on the secondary system producing pressure as designed.Additional testing included replacing the primary motor with a known functional motor used for testing.Driver passed all sections of functional testing with replacement primary motor.Failure investigation for this complaint confirmed the reported issue.The complaint was replicated during testing; root cause of the stuck primary motor was determined to be a faulty primary motor.Failure investigation identified damage to the exhaust fan cover due to wear and tear that was cosmetic and not related to the customer complaint.No other damage or test failures were identified that could have contributed to the complaint.Freedom driver did not function as designed.Device was not in patient use at time of complaint.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 syncardia service technician reported that the freedom driver had a primary motor that was stuck was not able to complete as received functional testing.

• 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: 16104237
• MDR Text Key: 306812802
• Report Number: 3003761017-2022-00146
• 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: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2018
• 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