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

Model Number 595000-001

Device Problem Noise, Audible (3273)

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

Event Date 09/05/2017

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because although the freedom driver exhibited an unusual noise it 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) initial.

Event Description

The customer, a syncardia certified hospital, reported that the freedom driver exhibited an unusual noise while supporting a patient.The customer also reported that the noise eventually self-terminated.The customer also reported that there was no alarm or change in driver function and the patient did not have any adverse impact.

Manufacturer Narrative

The freedom driver was returned to syncardia for evaluation.Visual inspection of the driver revealed no abnormalities.The driver in "as received" condition passed all required functional testing requirements, which included normotensive and hypertensive settings, with no anomalies or alarms or unusual noises.Additionally, an extended observation run test was performed and the driver performed as intended with no anomalies, unintended alarms or unusual noises.The customer-reported noise was not reproduced and therefore a root cause could not be determined.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 of this complaint and is closing this file.(b)(4) follow-up report 1.

Event Description

The customer, a syncardia certified hospital, reported that the freedom driver exhibited an unusual noise while supporting a patient.The customer also reported that the noise eventually self-terminated.The customer also reported that there was no alarm or change in driver function and the patient did not have any adverse impact.

• 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: 6876046
• MDR Text Key: 87755492
• Report Number: 3003761017-2017-00171
• 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: 09/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 09/18/2017
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/05/2017
• Initial Date FDA Received: 09/19/2017
• Supplement Dates Manufacturer Received: 03/16/2018
• Supplement Dates FDA Received: 04/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 21 YR