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

Model Number 595000-001

Device Problems Break (1069); Activation, Positioning or Separation Problem (2906); Audible Prompt/Feedback Problem (4020)

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

Event Date 03/11/2023

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 syncardia certified hospital, reported that upon start up the driver alarmed immediately.It was also reported that the beat rate was higher than was expected when it was set for a patient use.The driver was not connected to a patient during the system check.

Manufacturer Narrative

Alarm history and patient data file review found two new alarms, indicating secondary motor voltage is too high, recorded in the driver's fault alarm history.Visual inspection of internal components revealed a broken scotch yoke on the primary motor side of the piston cylinder assembly and the secondary motor cam follower is out of default position.Visual inspection of external components revealed no abnormalities.Driver failed incoming functional testing as the primary motor did not rotate when the driver had power and the piston cylinder assembly's yoke was broken on the primary side.Testing on the secondary system failed to meet specification requirements where beat rate should be 125 +/- 5 bpm.Immediate alarm condition and secondary motor engagement are indicative of a failure in the main printed circuit board assembly.The main printed circuit board assembly was removed and tested to determine functionality.The main printed circuit board assembly's f1 fuse was probed using a calibrated multimeter and no continuity was confirmed.The main board was confirmed to be the root cause of the customer reported issue.Failure investigation for this complaint confirmed the reported issue via alarm history data review and functional/observational testing.The complaint was replicated via functional/observational testing.The root cause of the alarm and high beat rate is a blown f1 fuse on the driver's main printed circuit board assembly.This failure mode was investigated under capa-0283 in 2019.Corrective action was implemented to prevent humidity in the fuse, which was determined to be the root cause of the failure (blown fuse).Record review showed the board installed in freedom driver s/n 5018 was manufactured in 2018 (pcba s/n s/n 201810550) prior to the corrective action implemented under the capa.There have been no failures related to the f1 fuse in product manufactured after corrective action was implemented.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.) (b)(4) llfollow-up report 1.

• 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: 16561058
• MDR Text Key: 311562521
• Report Number: 3003761017-2023-00029
• 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: Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 595000-001
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2017
• 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 Sex: Prefer Not To Disclose