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

Model Number 595000-001

Device Problems Device Displays Incorrect Message (2591); Audible Prompt/Feedback Problem (4020)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 05/14/2018

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because although the freedom driver exhibited a temperature alarm, it continued to perform 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 patient was checking on construction at his home when the freedom driver exhibited a temperature alarm.The patient opened up the backpack to allow cooler air onto the freedom driver in the backpack but did not exchange the freedom driver onboard batteries and the alarm continued.The customer also reported that the patient went to the hospital and was switched to a backup freedom driver.There was no reported adverse patient impact.

Manufacturer Narrative

The driver's alarm history was reviewed and revealed one alarm, '4f' fault code, left battery too hot, which correlates with the temperature alarm reported by the customer.The fault code was likely produced as a result of the freedom driver system being subjected to elevated temperatures for a long period of time.A temperature alarm is a recoverable alarm for 30 minutes.After 30 minutes in the alarm condition, it escalates to a permanent fault alarm that is latched in the alarm history.The driver in "as received" condition passed all test sections and pressure performance metrics associated with normotensive and hypertensive settings.Additionally, during an extended observation run test, the driver performed as intended with no abnormalities or unintended alarms.The customer-reported issue was not reproduced and there was no evidence of a device malfunction related to the customer-reported temperature alarm.The root cause of the customer-reported issue could not be conclusively determined.The temperature alarm was likely caused by the driver being exposed to high temperatures for a long period of time.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation 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: 7566359
• MDR Text Key: 110181857
• Report Number: 3003761017-2018-00209
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 09/14/2018

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: 05/21/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/14/2018
• Initial Date FDA Received: 06/04/2018
• Supplement Dates Manufacturer Received: 05/14/2018
• Supplement Dates FDA Received: 09/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR