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

Model Number 595000-001

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Patient Involvement (2645)

Event Date 09/14/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The freedom driver was not supporting a patient.The customer, a syncardia authorized distributor, reported that when the newly received freedom driver was taken out of its shipping case, the screw and cover for the potentiometer on the freedom driver were missing.

Manufacturer Narrative

The customer-reported missing potentiometer cover and (fastening) screw was confirmed during incoming evaluation of the driver.Visual inspection of the driver also identified a fractured display cover it is unknown when or how the display cover was damaged.Despite the missing potentiometer cover and fastening screw and display damage, the driver passed all functional testing.During investigation testing, the nut insert that is used to hold in the screw for the potentiometer cover was tested in an attempt to identify any physical damage or abnormalities, and no abnormalities were observed, as it was able to securely hold a screw with the potentiometer cover.Because the investigation confirmed the proper functionality of the driver and nut insert, it is possible that the potentiometer cover was not securely screwed on.The fastening screw is first applied at syncardia during servicing, and then is taken off by the clinician at the hospital to adjust and set the beat specific to each patient that the driver will be used for.It cannot be conclusively determined where or when this happened, as the driver was shipped to the customer from wwpl (syncardia distributor).As evidenced during the device history record review, the potentiometer cover was placed on the rear housing of the driver before being placed in finished goods.The cause of the missing potentiometer cover and fastening screw could not be conclusively determined, but is most likely the result of a workmanship issue as the cover and screw were missing from the shipping case.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 4470 follow-up report 1.

• Brand Name: SYNCARDIA FREEDOM DRIVER
• Type of Device: EXTERNAL PNEMATIC DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• MDR Report Key: 7901863
• MDR Text Key: 121466013
• Report Number: 3003761017-2018-00471
• 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: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 11/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2018
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2018
• Date Manufacturer Received: 09/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1