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

Model Number 595000-001

Device Problem Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Date 06/27/2019

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 will be 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 damaged and the cover could not be removed.

Manufacturer Narrative

The customer-reported issue of a broken screw was confirmed during visual inspection as the freedom potentiometer cover torx screw was revealed to have a bent center pin.The customer-reported issue of being unable to open the potentiometer cover was not able to be confirmed as the potentiometer cover torx screw was able to be removed with the l torx wrench.Despite the observed damage, the driver passed all sections of functional testing.The root cause of the damaged torx screw could not be conclusively determined, but it is likely that the torx screw became damaged due to improper use (use of an improper tool to remove/insert the screw).A specialized tool, the l torx wrench, is provided with the freedom driver tool kit to remove and insert the potentiometer cover torx screw.Freedom driver system operator manual for us, includes instructions for adjusting the beat rate of the freedom driver in section 7.7.The labeling states, "unscrew the setting dial cover on the back of the driver by using the l torx wrench." if this tool is not used to remove or insert the screw, it is likely that the torx screw would be damaged when adjusted with an improper tool.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.

• 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: 8791611
• MDR Text Key: 151127138
• Report Number: 3003761017-2019-00221
• 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: 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2019
• 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: 07/09/2019
• Date Manufacturer Received: 06/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1