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

Model Number 595000-001

Device Problems Device Displays Incorrect Message (2591); No Apparent Adverse Event (3189)

Patient Problems No Consequences Or Impact To Patient (2199); Patient Problem/Medical Problem (2688); No Known Impact Or Consequence To Patient (2692)

Event Date 02/24/2018

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because although the freedom driver exhibited a fault alarm, the freedom driver continued to perform 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 while supporting a patient.The customer also reported that the patient was symptomatic with low fill volumes and cardiac output.The customer also reported that the patient was subsequently switched to the backup freedom driver.There was no reported adverse patient impact.

Manufacturer Narrative

The driver in "as received" condition passed all test sections and pressure performance metrics associated with normotensive and hypertensive settings.The driver alarm history was reviewed and revealed a fault code 34.This alarm is recorded when there is an intermittent communication between the onboard batteries and the driver, which can be caused by an onboard battery exchange or as a result of an onboard battery not being fully latched into place or being damaged.The batteries in use at the time of the customer-reported experience were not returned and therefore could not be evaluated or included in this investigation.It cannot be determined if this alarm is the fault alarm reported or was recorded as a result of the battery exchange that occurred when the patient was switching drivers.An onboard battery exchange test was performed on the driver, and it performed as intended with no alarms produced.The customer-reported fault alarm could not be reproduced during investigation testing.The root cause of the customer-reported issue cannot be conclusively determined as the driver performed as intended with no evidence of a device malfunction.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.

Manufacturer Narrative

The driver in "as received" condition passed all test sections and pressure performance metrics associated with normotensive and hypertensive settings.The driver alarm history was reviewed and revealed a fault code 34.This alarm is recorded when there is an intermittent communication between the onboard batteries and the driver, which can be caused by an onboard battery exchange or as a result of an onboard battery not being fully latched into place or being damaged.The batteries in use at the time of the customer-reported experience were not returned and therefore could not be evaluated or included in this investigation.It cannot be determined if this alarm is the fault alarm reported or was recorded as a result of the battery exchange that occurred when the patient was switching drivers.An onboard battery exchange test was performed on the driver, and it performed as intended with no alarms produced.The customer-reported fault alarm could not be reproduced during investigation testing.The root cause of the customer-reported issue cannot be conclusively determined as the driver performed as intended with no evidence of a device malfunction.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.

Manufacturer Narrative

Corrected data in section b5 and h6.(b)(4) follow-up report 2.

Event Description

The customer, a syncardia certified hospital, reported that the freedom driver exhibited a fault alarm while supporting a patient.The customer also reported that the patient was symptomatic with decreased fill volumes and cardiac output impacting breathing, speaking and he felt like he was passing out.The customer also reported that the patient was successfully switched to the backup freedom driver.

• 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: 7312881
• MDR Text Key: 101709897
• Report Number: 3003761017-2018-00081
• 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,Followup
• Report Date: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2018
• 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: 03/15/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR