MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM ONBOARD BATTERY

Catalog Number 295025-001

Device Problems Defective Component (2292); Battery Problem (2885)

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

Event Date 08/25/2017

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to a patient because the issue was observed when the freedom onboard battery was not supporting a patient.The freedom onboard battery 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 onboard battery was not supporting a patient.The customer, a syncardia certified hospital, reported that the freedom onboard battery did not light any fuel gauge leds after charging.

Manufacturer Narrative

The freedom onboard battery was returned to syncardia for evaluation.The system management (smbus) flag data panels were reviewed and revealed that the battery exhibited a permanent fault input flag due to cell under-voltage conditions.The root cause for the battery's disabled output could not be conclusively determined; however, analysis of the smbus recorded data indicated that the battery was likely subjected to a deep discharge cycle with a prolonged duration prior to being recharged.The internal cells' natural self-discharge continued to drain the cells to an unsafe level, triggering its internal safety circuitry and permanently disabled the battery's input/output functions.A permanently faulted battery will display the state of charge when the permanent fault occurred when its gas gauge button is pressed while installed in a freedom battery charger, but will display zero bars of charge when the gas gauge button is pressed outside of the charger.Freedom driver system operator manual, section 6.5.1 checking onboard battery charge instructs patients to determine the charge status of each onboard battery before it is installed into a driver.Syncardia has a corrective and preventive action to address the issue of disabled battery output.Syncardia has completed its evaluation of this complaint and is closing this file.(b)(4) follow-up report 1.

Event Description

The freedom onboard battery was not supporting a patient.The customer, a syncardia certified hospital, reported that the freedom onboard battery did not light any fuel gauge leds after charging.

• Brand Name: SYNCARDIA FREEDOM ONBOARD BATTERY
• Type of Device: BATTERY
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• MDR Report Key: 6852784
• MDR Text Key: 85778471
• Report Number: 3003761017-2017-00160
• Device Sequence Number: 1
• Product Code: LOZ
• 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: 08/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 295025-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1