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 High Blood Pressure/ Hypertension (1908); No Consequences Or Impact To Patient (2199)

Event Date 04/09/2018

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, 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 freedom driver exhibited a fault alarm while supporting a patient.The customer also reported that the patient was hypertensive at the time of the driver fault alarm because the patient forgot to take his antihypertensive medication that morning.The customer also reported that the freedom driver "responded appropriately and alarmed to alert the patient to the situation." the customer also reported that the patient was switched to a backup freedom driver without any adverse patient impact.

Manufacturer Narrative

The customer-reported fault alarm was only able to be reproduced when the freedom driver was tested at hypertensive settings similar to the reported patient hypertensive conditions.The alarm cleared as designed when the cardiac output returned to normotensive conditions.The driver passes all functional testing and 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.

• 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: 7454251
• MDR Text Key: 106599394
• Report Number: 3003761017-2018-00132
• 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: 08/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• 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: 04/18/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 53 YR