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

Model Number 595000-001

Device Problems Device Alarm System (1012); Electrical /Electronic Property Problem (1198); Device Displays Incorrect Message (2591)

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

Event Date 11/02/2017

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because the freedom driver continued to perform its life-sustaining functions.Syncardia has made repeated requests to the customer to obtain information to clarify the customer-reported issue, including product serial numbers, and has requested the freedom driver, onboard batteries, and freedom ac power supply supporting the patient at the time of the issue 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 low battery alarms while the driver was attached to wall power in the middle of the night and instances in which no alarm sounded despite the battery power being low while on battery power.The customer also reported that the patient was subsequently switched to the backup freedom driver.There was no reported adverse patient impact.No additional information has been received at this time.

Manufacturer Narrative

The driver passed all sections of functional testing.Additionally, a battery exchange test was performed on the driver, and it performed as intended.The onboard batteries, battery charger and ac power supply used by the patient during the reported experience were returned with the driver, evaluated herein and were all determined to function as intended.During investigation testing, a low battery alarm was reproduced when the onboard battery (returned as part of reported issue) was below 35% charge, but the alarm recovered, as designed, when the driver was connected to external power, and there was no evidence of a device malfunction.Only permanent fault alarms are recorded in the driver's alarm history; battery alarms or other intermittent and recoverable alarms are not recorded.The root cause of the customer-reported low battery alarm while connected to wall power could not be conclusively determined, but was likely caused by an onboard battery in the driver being under 35% charge.The root cause of the reported instance of no alarm despite battery power being low and the driver only running on battery power could not be determined.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: EXERNAL PNEUMATIC DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: kerri hensley ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 7084231
• MDR Text Key: 94991653
• Report Number: 3003761017-2017-00223
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003121
• UDI-Public: (01)00858000003121
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2017
• 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: 12/27/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 39 YR