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 10/07/2019

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses low risk to the patient because the reported issue did not prevent the 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 an intermittent battery alarm while supporting a patient.There was no reported 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 revealed three alarms, 2d, 4b, and 4a, fault code alarms.The 2d fault code alarm was likely produced at syncardia during the last servicing of the driver prior to shipment to the customer as there was no evidence of secondary motor engagement.The 4b and 4a fault code alarms are typically produced after disconnecting the driver from the patient.No permanent alarms were reported by the customer.The driver passed all sections of functional testing without any alarms or abnormalities.Additionally, an extended observation run test was performed using the freedom onboard batteries returned with the driver.No alarms were produced during the extended observation run.An onboard battery exchange test was also performed on the driver in an attempt to reproduce the customer-reported issue.No alarms were produced during this test either.The driver performed as intended with 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 4997 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: 9197562
• MDR Text Key: 162550492
• Report Number: 3003761017-2019-00302
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 12/16/2019

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: 10/08/2019
• Initial Date Manufacturer Received: 10/07/2019
• Initial Date FDA Received: 10/16/2019
• Supplement Dates Manufacturer Received: 10/07/2019
• Supplement Dates FDA Received: 12/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 40 YR