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MDA/2006/058 - Volumetric Infusion Pump: Alaris SE pump - all models

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Document details:

Type: Medical Device Alert
Series No: MDA/2006/058
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 8
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Issued: 05 October 2006 at 11:00
Ref: MDA/2006/058

 

Tick mark
Immediate action
 
Action
 
Update
 
Information request


Device:
Volumetric Infusion Pump: Alaris SE pump - all models
(formerly the Signature Edition Infusion pump). Manufactured by Cardinal Health (formerly known as Alaris).

>Page 2

Problem:
Unintended double key entries, also known as 'key bounce', due to a problem with the control keypad. This causes a number entered on the keypad to register twice although the operator only pressed the key once. There is a potential for a ten times over-infusion due to this key bounce with all models of the Alaris SE pumps (see Appendix in pdf).

>Page 2

Action by:
All nursing, medical and technical staff using these devices.		  

Action:

  • Contact Cardinal Health (Alaris) to obtain warning labels for the pumps (see Appendix in pdf).
  • Attach the Alaris warning labels to all Alaris SE pumps.
  • Check the pump's settings before starting the infusion.

>Page 2

Distributed to:

NHS trusts in England - Chief Executives*
Commission for Social Care Inspection (CSCI) - Headquarters
Healthcare Commission (CHAI) - Headquarters
Primary care trusts in England - Chief Executives*

* via CE Bulletin

>Page 2

Contacts:
Details of manufacturer contacts and MHRA contacts for technical and clinical aspects.
Change of address or removal from address list for CSCI and Healthcare Commission.

>Pages 2-3

Appendix:
Manufacturer's letter. (pdf only)

>Pages 4-8



Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 19 October 2006
Deadline (action complete): 28 December 2006


Page last modified: 07 February 2008