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

Catalog Number 295025-001

Device Problems Overheating of Device (1437); Battery Problem (2885)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 09/26/2017

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because it did not prevent the freedom driver from performing its life-sustaining functions.In addition, 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.Ce 3987 initial.

Event Description

The customer, a syncardia certified hospital, reported that the freedom onboard battery got very hot when it was in the patient's freedom driver.There was no reported adverse patient impact.

Manufacturer Narrative

Initial investigation and review of onboard battery system management (smbus) data confirmed that the battery had reached 48°c, which is the battery temperature that would signal the driver to annunciate a temperature alarm, as well as likely feel hot to the touch as reported by the customer.The batteries were most likely replaced prior to alarm annunciation as no temperature alarm was reported by the customer, and it cannot be determined when the battery reached this temperature (inside or outside of the driver).The battery was tested in accordance with current evaluation process, where it successfully passed all sections.There is no evidence from the smbus data analysis or evaluation testing indicating that a malfunction of the battery caused the temperature to increase, or that it functioned outside its intended design.The root cause for the battery reaching 48°c cannot be conclusively determined; however, it can be caused by operating a freedom driver in elevated ambient temperatures, blocking the driver air cooling intake / exhaust vents or a combination of both.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.(b)(4) 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: 6907586
• MDR Text Key: 89644799
• Report Number: 3003761017-2017-00193
• 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: health professional,user faci
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 09/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 295025-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/26/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 20 YR