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Paradigm Insulin Infusion Pump. Priority 2 – Warning

Notice type: Warning

Date: 24/04/2014

  

Product name or type:
Paradigm Insulin Infusion Pump. Priority 2 – Warning

Reference:
SN2014(20)

Manufacturer Or Supplier:
Medtronic MINIMED

Target Audience:
All Hospital Staff 
All Nursing Home Staff 
A&E Departments 
Ambulance Service 
Cardiology Departments 
Cardiothoracic Departments 
Carers 
Chief Executive Officers 
Clinical Directors 
Day Surgery Units 
Emergency Medical Technicians 
Diabetic Clinics/ outpatients 
Diabetic nurse specialists 
Diabetic departments 
Endocrinology units 
Endocrinology Consultants 
Gastroenterology Departments 
General Practitioners 
General Public 
Haemodialysis Units 
Healthcare professionals who use these devices 
Healthcare professionals managing patients who use these devices 
High Dependency Units 
Hospital Managers 
Hospital Pharmacists 
Intensive Care Units 
IV Nurse Specialists 
Maternity Units 
Midwifery Departments 
Neonatology Departments 
Nursing Managers 
Nursing staff 
Obstetrics and Gynaecology Departments 
Oncology Nurse Specialists 
Paediatric Departments 
Paramedics 
Peritoneal Dialysis Units 
Purchasing / Procurement / Material Managers 
Renal Medicines Departments 
Resuscitation Officers 
Risk Managers 
Supplies Managers 
Theatre Managers and nurses 
Urology Departments

Problem Or Issue:
Medtronic has received a number of reports regarding users who have accidentally programmed the pump to deliver the maximum bolus amount, including one incident that resulted in severe hypoglycaemia. 

All insulin delivery programmed through the Main Menu will allow the down arrow button to scroll from 0.0 units to the programmed maximum bolus insulin dose.

Background Information Or Related Documents:
Paradigm Insulin Infusion Pump. Priority 2 – Warning Document

This action applies to Paradigm Pump models MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515, MMT-715, MMT-522, MMT-522K, MMT-722, MMT-722K, MMT-523, MMT-523K, MMT-723, MMT-723K, MMT-554, and MMT-754. 

When using the Express Bolus button to deliver a bolus, the down arrow will scroll to 0.0 units and stop. 

Because accidental button pressing errors may occur, it is important that patients always confirm the insulin dose flashing on the display is correct before pressing ACT to start delivery. 

The IMB is working with Medtronic and the HSE to ensure awareness of this issue.

Actions To Be Taken:
The IMB advise that users: 

(1) Follow the instructions outlined by the manufacturer in the field safety notice (FSN) attached. 

(2) When programming insulin doses through the Main Menu, pay close attention because scrolling down allows the dose displayed on the screen to go from 0.0 units to the maximum programmed insulin dose. 

(3) Always confirm the insulin dose flashing on the display is correct before pressing ACT to start delivery. 

(4) The Max Bolus and Max Basal safety limits should be programmed in your patients’ pumps according to their individual insulin needs. 

(5) Forward this IMB Safety Notice to all those within your organisation that need to be aware of this information. Please also pass this Safety Notice and the attached FSN on to any end users or organisations where these devices may have been distributed.

Further Information:
Enquiries to the manufacturer should be addressed to: 

Medtronic MINIMED 
18000 Devonshire Street 
CA 91325 -1219 
Northridge 
USA 
Telephone: +1 818 576 5555 
Fax: +1 818 365 2246 
E-mail: N/A 
Website: N/A 

Enquiries to the distributor should be addressed to: 
Medtronic Limited 
Building 9 Croxley Green Business Park 
WD18 8WW 
Watford 
United Kingdom 
Telephone: +44 1923 212213 
Fax: N/A 
E-mail: vigilance.eu@medtronic.com 
Website: N/A 

All adverse incidents relating to a medical device should be reported to: 

Health Products Regulatory Authority
Human Products Monitoring 
Kevin O’Malley House 
Earlsfort Centre 
Earlsfort Terrace 
Dublin 2 

Telephone: +353-1-6764971 
Fax: +353-1-6344033 
E-mail: devicesafety@hpra.ie
Website: www.hpra.ie 

Please click here to view a PDF version of this safety notice

Please click here to view a copy of FSN 1

Please click here to view a copy of FSN 2

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