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

Catalog Number 595000-001

Device Problems Difficult to Insert (1316); Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Date 05/05/2017

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 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 a freedom driver onboard battery would intermittently stick when inserted into, or removed from, the freedom driver battery well.

Manufacturer Narrative

The freedom driver was returned to syncardia for evaluation.Visual inspection of the internal components of the driver revealed a bent dummy battery.The customer-reported onboard battery insertion issue was reproduced and confirmed by positioning the damaged dummy battery inside the driver with the bent side against the safety battery latch.Testing using the onboard batteries used by the patient at the time of the customer experience could not be included in this investigation because the onboard batteries were not returned by the customer.The most likely cause of the customer-reported issue is interference in the onboard battery exchange process during driver start-up as a result of damage that occurred to the orange dummy battery.It is unknown when the damage to the orange dummy battery occurred.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 a freedom driver onboard battery would intermittently stick when inserted into, or removed from, the freedom driver battery well.

• 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: 6559315
• MDR Text Key: 75018248
• Report Number: 3003761017-2017-00080
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2013
• 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