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

Model Number 595000-001

Device Problems Device Displays Incorrect Message (2591); Audible Prompt/Feedback Problem (4020)

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

Event Date 12/11/2017

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) initial.

Event Description

The customer, a syncardia certified hospital, reported that the freedom driver exhibited a fault alarm for low cardiac output while supporting a patient.The customer also reported that the patient was switched to a back-up 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.Additionally, during an extended observation run test, the driver performed as intended and cardiac output remained within specifications.The customer-reported issue of a fault alarm for low cardiac output 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.

• Brand Name: SYNCARDIA FREEDOM DRIVER
• Type of Device: EXTERNAL PNUEMATIC DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: michael garippa ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 7138740
• MDR Text Key: 95960158
• Report Number: 3003761017-2017-00256
• 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: 07/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• 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: 12/19/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2017
• 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: 48 YR