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

Model Number 295025-001

Device Problem Failure to Charge (1085)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 08/01/2019

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to a patient because patients are provided with several onboard batteries, and the freedom driver has a redundant power source of external wall power.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 customer, a syncardia certified hospital, reported that the patient's freedom onboard battery was unable to charge.There was no reported adverse patient impact.

Manufacturer Narrative

Visual inspection of the onboard battery revealed multiple scratches and separation of the battery housing.Initial system management (smbus) data review could not confirm any permanent faults; however, functional testing revealed the battery was not able to receive or output any power due to being permanently disabled by its safety monitor.The absence of permanent faults in the smbus data most likely means that the permanent fault was caused by activation of the secondary hardware protection circuit.Activation of the secondary hardware protection circuit most likely resulted from a disconnection between one of the battery cells and the main circuit.This likely is a result of the battery being subjected to rough handling or an impact shock, as evidence by the observed physical damage.Syncardia has a corrective and preventive action (capa) to track and address any applicable actions related to permanently faulted onboard batteries.Syncardia has completed its evaluation of this complaint and is closing this file.Ce 4909 follow-up report 1.

• 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: 8937086
• MDR Text Key: 159643198
• Report Number: 3003761017-2019-00246
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003084
• UDI-Public: (01)00858000003084
• 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
• Type of Report: Initial,Followup
• Report Date: 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 295025-001
• Device Catalogue Number: 295025-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Date Manufacturer Received: 08/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR