Health product recall

Medfusion Syringe Infusion Pumps

Last updated

Summary

Product
Medfusion Syringe Infusion Pumps
Issue
Medical devices - Software defect
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products

Lot or Serial Number

Model or catalog number

Medfusion 3500 Syringe Infusion Pump

More than 10 numbers, contact manufacturer.

3500-0600-50, 3500SD-500, 3500VX-500, 3500VX-415, 3500, 3500-415, 3500-306, 3500-414, 3500-500, 3500SD, 3500VX-306

Medfusion 4000 Syringe Infusion Pump

More than 10 numbers, contact manufacturer.

4000-0100-51, 4000-0101-50, 4000-0105-51, 4000-0601-01, 4000-0101-295, 4000-0101-95, 4000-0106-00, 4000-0106-01, 4000-0101-78, 4000-0100-50, 4000-0100-295, 4000-0100-95, 4000-0101-51, 4000-0100-249

Issue

Smiths Medical became aware of eight (8) issues-(identified below) that can potentially occur that may impact therapy delivery in specific Medfusion 3500 and 4000 syringe infusion pumps.
1. Primary Audible Alarm (PAA)
2. Unanticipated depleted battery alarms
3. Time Base Alarm
4. Intermittent Volume Over Time
(IVOT) - Infusion continues after system fault
5. Clearing of Program Volume Delivered (PVD)
6. False Alarm for Rate below recommended minimum for syringe size
7. Incorrect bolus or loading dose time display
8. Domain Name Server (DNS) port 1001 and when some of these issues happen, It may lead to delay in therapy or interruption of therapy, which may result serious injuries to patients.

Recall start date: Mar 28, 2022

Additional information

Details
Original published date: 2022-04-13
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies

Smiths Medical Asd, Inc.

6000 Nathan Lane N., Minneapolis, Minnesota

United States, 55442

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type I
Identification number
RA-64065