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

Model Number 595000-001

Device Problems Display or Visual Feedback Problem (1184); Failure of Device to Self-Test (2937)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 11/24/2017

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to a patient because the issue was observed when the freedom driver was not supporting a patient.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 it is unclear if the freedom driver ever supported a patient.The customer also reported that it is unclear if this freedom driver ever had an issue.The customer also reported that it is unclear if this is the freedom driver which only showed asterisks on the display when tested and did not pass checkout procedures.When the freedom driver was checked again, there were no issues.

Manufacturer Narrative

The freedom driver was returned to syncardia for evaluation.The driver in "as received" condition passed all required functional testing requirements, which included normotensive and hypertensive settings.As the customer-reported issue has historically been produced by a malfunction of the flow sensor cable, the flow sensor cable was removed from the driver and inspected for physical damage.No damage to the flow sensor cable was observed.The customer-reported issue was not reproduced during investigation testing and there was no evidence of a device malfunction.The root cause of the customer-reported issue cannot be conclusively determined.This issue will 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.

Event Description

The customer, a syncardia certified hospital, reported that it is unclear if the freedom driver ever supported a patient.The customer also reported that it is unclear if this freedom driver ever had an issue.The customer also reported that it is unclear if this is the freedom driver which only showed asterisks on the display when tested and did not pass checkout procedures.When the freedom driver was checked again, there were no issues.

• 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: 7084355
• MDR Text Key: 94991032
• Report Number: 3003761017-2017-00246
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 11/24/2017

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: Health Professional
• Device Model Number: 595000-001
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1