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 12/30/2019

Event Type  malfunction  

Manufacturer Narrative

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.The patient was switched to a backup driver and there was no reported adverse patient impact.

Manufacturer Narrative

The driver's alarm history was reviewed and revealed one new fault code.A '4b' fault code alarm is typically produced when the driver is disconnected from the patient and most likely occurred when the driver was being switched off the patient.Only permanent alarms are recorded in the history; intermittent and/or recoverable alarms would not be recorded.The driver passed all sections of functional testing.Additionally, an onboard battery discharge/ recharge test and an onboard battery exchange test were performed.The driver functioned as intended with no alarms produced during both tests.During investigation testing, the customer-reported issue was not able to be reproduced and there was no evidence of a device malfunction.It is possible the customer-reported alarm was a battery alarm.A battery alarm is recoverable and would not be recorded in the driver's history unless the alarm was unaddressed for 4 minutes and 15 seconds.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 5136 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: 9627248
• MDR Text Key: 177378325
• Report Number: 3003761017-2020-00030
• 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: 02/05/2020

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 Model Number: 595000-001
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Initial Date Manufacturer Received: 12/30/2019
• Initial Date FDA Received: 01/24/2020
• Supplement Dates Manufacturer Received: 12/30/2019
• Supplement Dates FDA Received: 02/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 48 YR