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

Model Number 595000-001

Device Problems Noise, Audible (3273); Audible Prompt/Feedback Problem (4020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/10/2019

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 will be 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 and an "air leaking" sound 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

Visual inspection of the driver revealed broken housings, a fractured fan cover, and a fractured display cover.The driver's alarm history was reviewed and revealed one new alarm, a 36 fault code.This alarm can produced during an onboard battery exchange or as a result of impact shock suffered by the driver while operating and causing power communication errors.This alarm is most likely the alarm reported by the customer.The driver in "as received" condition passed all sections of functional testing.Additionally, an onboard battery exchange test was performed and the driver did not exhibit any alarms.An extended observation run was performed in an attempt to observe the customer-reported air leaking sound.During the extended observation run, the driver functioned as intended and no air leaking sounds could be heard.During investigation testing, the driver functioned as intended and there was no evidence of a device malfunction.The root cause of the customer-reported issue could not be conclusively determined.It is possible the alarm occurred because the driver experienced an impact shock, as evidenced by the damage observed during visual inspection, causing power communication errors.The reported air-leaking sound could not be confirmed.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.(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
• MDR Report Key: 9214158
• MDR Text Key: 163063927
• Report Number: 3003761017-2019-00307
• 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: 11/25/2019

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: 10/25/2019
• Initial Date Manufacturer Received: 10/10/2019
• Initial Date FDA Received: 10/21/2019
• Supplement Dates Manufacturer Received: 10/10/2019
• Supplement Dates FDA Received: 11/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 46 YR