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 10/14/2019

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 authorized distributor, reported that the patient was sleeping and the freedom driver exhibited a continuous fault alarm while supporting the patient.There was no reported adverse patient impact.The customer also reported that the patient was subsequently switched to a backup driver.

Manufacturer Narrative

Visual inspection of the driver revealed a fractured filter cover.The secondary motor's cam follower was also found to be out of the bottom dead center (bdc) position, which can be indicative of secondary motor engagement.The driver's alarm history was reviewed and revealed one new alarm, a 12 fault code.This alarm is recorded when the primary motor fails to engage or stops operating, which causes the driver to revert to secondary motor operation.During extraction of the alarm data, it was observed that the primary motor was making a scratching noise and its rotation was noticeably rough and uneven.Despite this observation, the driver passed all sections of functional testing on both the primary and secondary systems.During investigation testing, the customer-reported alarm could not be reproduced.The fault alarm could have been produced by an intermittent failure of the primary motor, causing the driver to operate on the secondary system.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: 9214145
• MDR Text Key: 163064090
• Report Number: 3003761017-2019-00311
• 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: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 11/27/2019

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: 10/21/2019
• Initial Date Manufacturer Received: 10/15/2019
• Initial Date FDA Received: 10/21/2019
• Supplement Dates Manufacturer Received: 10/15/2019
• Supplement Dates FDA Received: 12/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 52 YR