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

Model Number 595000-001

Device Problems Device Displays Incorrect Message (2591); Failure of Device to Self-Test (2937); No Apparent Adverse Event (3189)

Patient Problem No Patient Involvement (2645)

Event Date 11/22/2017

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) initial.

Event Description

The freedom driver was not supporting a patient.The customer, a syncardia certified hospital, reported that the freedom driver exhibited a fault alarm and did not pass the system check out procedure.

Manufacturer Narrative

The driver in "as received" condition passed all test sections and pressure performance metrics associated with normotensive and hypertensive settings.Additionally, an extended observation run test was performed on the driver and it performed as intended with no alarms.The driver was power cycled several times, during which time the rv1 potentiometer on the main printed circuit board assembly (pcba) was tested and the driver performed as intended with no inconsistencies in performance.The customer-reported fault alarm upon startup and slow rev up to speed was not confirmed or reproduced.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.

• 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: 7084356
• MDR Text Key: 95072673
• Report Number: 3003761017-2017-00244
• 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: 07/11/2018

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: 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: 11/22/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1