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

Model Number 595000-001

Device Problems Break (1069); Output Problem (3005)

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

Event Date 03/17/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

While performing a routine evaluation, a syncardia technician reported that the freedom driver did not maintain the proper normotensive pressure values on the patient simulator.

Manufacturer Narrative

Alarm history data review confirmed that no new permanent alarms occurred in the field prior to the driver returning to syncardia for service.Visual inspection of external components found a split in the o-ring on the male cpc connector (red side) of the driveline.Visual inspection of internal components found scuff marks on the main pcb and primary motor bezel indicating contact during operation and a melt mark on the speaker cable next to the primary motor.During set up, prior to functional testing, a leaking sound was observed coming from the male cpc connector.The damaged o-ring was suspected to be the cause of the leaking sound.Because of this, the o-ring was replaced and functional testing was repeated with passing results.The o-ring was determined to be the root cause of the low lap testing failure.Unrelated to the test failure that led to this complaint, during the investigation, the secondary motor was found to not meet specification requirements for manual manipulation.The driver failed functional testing at incoming inspection because of a leak at the cpc connector, red side, on the driveline.The leak was caused by a split in the o-ring on the cpc connector.As this issue was discovered during servicing at syncardia, no test to replicate the issue was required.No additional investigation or escalation is required at this time.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).Follow-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: 11582411
• MDR Text Key: 244169842
• Report Number: 3003761017-2021-00041
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 595000-001
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2019
• 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