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

Model Number 595000-001

Device Problems Break (1069); Mechanical Problem (1384); Difficult to Remove (1528)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 01/03/2018

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to a patient because the issue was observed while the freedom driver was not supporting a patient.The damaged torx-head screw and the freedom driver were not returned to syncardia for evaluation.The results of the freedom driver device history record review will be provided in a follow-up mdr.(b)(4).

Event Description

The customer, a syncardia certified hospital, reported that the torx-head screw that secures the beat rate cover onto the freedom driver was damaged and could not be removed with the proper syncardia provided tool.The customer also reported that the damaged torx-head screw was removed using a jeweler's screwdriver and discarded.The customer also reported that a replacement torx-head screw was received from syncardia and properly used to secure the beat rate cover onto the freedom driver.

Manufacturer Narrative

The screw was not returned to syncardia therefore a visual inspection could not be performed.However the customer provided a picture indicating a bent pin on the security screw of the rate adjustment door on the driver.A review of the driver's device history record (dhr) confirmed that the driver was serviced according to freedom driver service procedure in effect at the time with no issues.The driver passed all functional testing per freedom driver final test and acceptance procedure, with no issues recorded, before being placed into finished goods.It cannot be conclusively determined how the security screw pin became bent.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.Ce 4104 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: 7206077
• MDR Text Key: 97971361
• Report Number: 3003761017-2018-00017
• 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: 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2018
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1