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

Model Number 595000-001

Device Problem Audible Prompt/Feedback Problem (4020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2019

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because the reported issue did not prevent the freedom driver from performing its life-sustaining functions.The freedom driver has been returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4).

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 freedom driver.

Manufacturer Narrative

The driver's alarm history was reviewed and did not reveal any new alarms; intermittent and/or recoverable alarms are not recorded.The driver passed all sections of functional testing without any alarms or abnormalities.Additionally, an observation run was performed on the driver and no alarms were produced during this test.The customer-reported alarm was not reproduced and there was no evidence of a device malfunction.The root cause of the customer-reported issue could not be conclusively determined.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation of this complaint and is closing this file.Ce 5054 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
• MDR Report Key: 9345065
• MDR Text Key: 167172312
• Report Number: 3003761017-2019-00334
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003121
• UDI-Public: (01)00858000003121
• Combination Product (y/n): N
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 595000-001
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2019
• Date Manufacturer Received: 11/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 48 YR