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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 068 06 18 001
Date submitted: 7/26/2018
Manufacturer:C R Bard Inc
Device Type:ARCTIC SUN 5000 Temperature Management System
Description:Temperature Management System
Medical Device Identifier:Product Code: 5000-01-01, 5000-01-02, 5000-01-07

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FDA update code:

Model #5000 Product codes: 5000-00-00, 5000-00-00L, 5000-00-00E, 5000-01-01, 5000-01-01L, 5000-01-02, 5000-01-03, 5000-01-04, 5000-01-05, 5000-00-06, 5000-01-07, 5000-01-08.
All serial numbers are affected.
Reason of Field Safety Corrective Action:Bard has received six (6) reports of an electrical burning smell coming from six distinct Arctic Sun 5000 Temperature Management Systems at a rate of 0.12% of distributed units.
Remedy Action:1. Examine your inventory and identify any Arctic Sun 5000 Temperature Management Systems that is associated with this communication.

2. Pass this customer notification to all those who need to be aware of it within your organisation.

3. If you have distributed or transferred an Arctic Sun 5000 Temperature Management System, please identify the respective organisations and notify them at once of this communication, including a copy of this communication letter. This should be carried out to the Arctic Sun unit level.

4. You will be contacted by a Bard agent or authorised representative to schedule your unit(s) for repair.
Athorized Representative/Importer/Distributor:C.R. BARD Saudi Arabia
Report Source:https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165300
Source Ref. Number:Z-2536-2018
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments