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

Model Number 595000-001

Device Problems Difficult to Remove (1528); Sticking (1597)

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

Event Date 07/18/2017

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 freedom onboard batteries were stuck in the driver and had to be pried out.

Manufacturer Narrative

The freedom driver was returned to syncardia for evaluation.The customer-reported battery extraction difficulty was confirmed and reproduced during investigation testing.Visual inspection of the driver found extensive damage to the left battery well and button and a broken right safety battery latch, indicating rough handling/improper use.The broken right safety battery latch did not allow the left onboard battery to be removed by hand from the driver during the onboard battery insertion/extraction test, confirming the customer-reported issue.The root cause of the onboard battery not being able to be removed from the driver is the broken safety battery latch.The right safety battery latch was found to be damaged, most likely caused by rough insertion of the batteries into the driver.A broken safety battery latch may prevent a battery from being extracted from the driver or from being fully latched into place.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 freedom driver was not supporting a patient.The customer, a syncardia certified hospital, reported that the freedom onboard batteries were stuck in the driver and had to be pried out.

• Brand Name: SYNCARDIA FREEDOM DRIVER
• Type of Device: EXTERNAL PNEUMATIC DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: michael garippa ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 6753864
• MDR Text Key: 81610021
• Report Number: 3003761017-2017-00136
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003121
• UDI-Public: (01)00858000003121
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2017
• 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: 07/24/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1