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

Model Number 595000-001

Device Problem Material Integrity Problem (2978)

Patient Problem No Patient Involvement (2645)

Event Date 04/11/2019

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 freedom driver was not supporting a patient.The customer, a syncardia certified hospital, reported that the screw head on the freedom driver beat rate cover screw was stripped and could not be removed.

Manufacturer Narrative

Visual inspection confirmed the customer-reported issue of a damaged potentiometer cover torx screw.The root cause of the damaged potentiometer cover torx screw cannot be conclusively determined but is likely due to improper use (incorrect tool to remove or insert the screw).A specialized tool, the l torx wrench, is provided with the freedom driver toolkit to remove and screw in the potentiometer cover torx screw.F-900013-en, freedom driver system operator manual for us, describes instructions for adjusting the beat rate of the freedom driver in section 7.7.Labelling states, "unscrew the setting dial cover on the back of the driver by using the l torx wrench." if this tool was not used to insert or remove the screw, it is very likely that the torx screw would be damaged when adjusted with an improper tool.Despite the observed damage, the driver passed all sections of functional testing.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.Ce 4744 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: 8593383
• MDR Text Key: 144563269
• Report Number: 3003761017-2019-00087
• 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
• Type of Report: Initial,Followup
• Report Date: 07/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2019
• 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: 04/17/2019
• Date Manufacturer Received: 04/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1