Smith Medfusion 3500 Manual

Smith Medfusion 3500 Manual

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Smiths Medical Medfusion 4000 The Smiths Medical Medfusion 4000 is a syringe pump with human and veterinary drug library capabilities. It has the same great features of the 3500 with the ease of wireless drug capabilities. MEDEX Medfusion 3500 Medex Operation Manual Artwork GD000608 Revision 5 Page 2 2. INTRODUCTION The Medfusion 3500 syringe infusion pump is designed for use in critical care areas for the administration of fluids requiring precisely controlled infusion rates. Because of the pump's simplicity and ease of use, this pump can also be.
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 Class 2 Device Recall Medfusion Syringe Pump, 3500 Series
Date Initiated by FirmAugust 22, 2017
Create DateJanuary 04, 2018
Recall Status1Open3, Classified
Z-0314-2018
Recall Event ID77761
K040899
Pump, infusion - Product CodeFRN
ProductMedfusion, Syringe Infusion Pump, Software Version 6 (V6), Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK. 
In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids.
Code InformationModel No. 3500; Reference No. 3500-0600-51
Recalling Firm/
Manufacturer Smiths Medical ASD Inc.
 6000 Nathan Ln N
 Minneapolis MN 55442-1690
For Additional Information ContactTechnical Service
800-258-5361 
Potential for the syringe barrel clamp mechanism to loosen, decreasing the pump's ability to accurately detect the diameter of the syringe barrel, resulting in the unit to initiate the 'Invalid Syringe Size' alarm. 
Component design/selection
The firm,Smiths Medical, sent an, 'Urgent Medical Device Recall' Amendment Notice (amending the original August 2017) concerning 001cinvalid syringe size alarms001d on certain Medfusion¿ Syringe Pump Model Series 3500 and 4000. The letter described the product, problem, actions to be to taken, and updated changes, as follows: 1. Locate the affected Medfusion¿ Syringe Pump(s) by referring to the list of affected devices on the attached Urgent Medical Device Recall Notice Response Form. This form provides the specific serial number(s) your organization purchased. Each pump has a unique serial number which can be found on the label located on the bottom of the pump. If you have ten (10) or more affected pumps in your possession, please select one of the following repair options: a. Repair at your Facility: Contact Smiths Medical to schedule a technician to visit your facility and complete the necessary repairs onsite. b. Send to Smiths Medical for Repair: Impacted pumps may be sent to a Smiths Medical Service Center, where repairs will be completed. A prepaid shipping label will be provided. Repairs will be completed within ten (10) business days of receipt. Loaner units are available upon request. c. NEW OPTION - Biomedical Department self-repair at your Facility: Contact Smiths Medical to receive the necessary parts and work instruction to have your biomed team complete the necessary repairs onsite. If you have nine (9) or fewer affected pumps in your possession: a. Send to Smiths Medical for Repair: Impacted pumps may be sent to a Smiths Medical Customer Service Center, where repairs will be completed. A prepaid shipping label will be provided. Repairs will be completed within ten (10) business days of receipt. Loaner units are available upon request. b. NEW OPTION - Biomedical Department Self-Repair at Your Facility: Contact Smiths Medical to receive the necessary parts and work instruction to have your biomed team complete the necessary repairs onsite. To initi
9,787 units in total
Worldwide Distribution: US (Nationwide) and countries of: Canada, Great Britain, Panama, Germany, India, Philippines, and Oman.
TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes. 
510(K) Database510(K)s with Product Code = FRN and Original Applicant = MEDEX, INC.
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Graseby Instruction Manuals
This publication has been compiled and approved by Graseby
Medical Ltd for use with their respective products. It is supplied

Graseby Instruction Manuals
This publication has been compiled and approved by Graseby
Medical Ltd for use with their respective products. It is supplied
in this format to permit users to access the text and illustrations
for their own use e.g. training and educational purposes.
Users of the equipment must ensure that they have read and
understood the contents of the complete manual including the
warnings and cautions and have been trained in the correct use
of the product.
Graseby Medical Ltd cannot be held responsible for the
Smith Medical Medfusion 3500 Manualaccuracy and any resulting incident arising from information
that has been extracted from this manual and compiled into the
users documentation.
Medfusion 3500 BatteryThese manuals are subject to revision and it is the users
responsibility to ensure that the correct version of manual/
text/illustration is used in conjunction with the equipment.