HAZARD NOTICE By arrangement with the Scottish Executive Health Department

Transcription

1 HAZARD NOTICE By arrangement with the Scottish Executive Health Department ALARIS SE PUMPS (ALL MODELS): POSSIBLE OVER-INFUSION DUE TO KEYPAD ANOMALY HAZ(SC)06/21 09 OCT 2006 Page 1 of 7 Pages SUMMARY Alaris SE pumps may deliver an over-infusion due to a control keypad anomaly. Warnings labels should be applied and extra care should be taken when keying entries. BACKGROUND 1. Cardinal Health 303, Inc., a wholly-owned subsidiary of Cardinal Health Inc. (Cardinal Health), manufacture and distribute the Alaris SE pump (see Figure 1, page 2). These pumps were previously sold as the Signature Edition Infusion Pump. 2. Cardinal Health has advised that these pumps have been associated with a control keypad anomaly known as key bounce. A letter was issued to customers on 26 September 2006 (see Annexe 1). 3. Key bounce causes a number entered on the control keypad to register twice although the operator only pressed the key once. These unintended double entries can result in an over-infusion of up to or in excess of ten times the inputted rate, depending on how many times the key bounces. 4. Cardinal Health has advised that all models of the Alaris SE pumps are affected, but other IVAC/Alaris or Cardinal Health volumetric pumps, Alaris GW (formerly Asena), Alaris GP, Gemini Infusion System, 571/572 and 597/598 families of pumps are not affected. 5. Cardinal Health has stopped supplying new Alaris SE pumps and is evaluating a design improvement to minimise the potential for key bounce to occur. When the solution has been developed it will be made available to Alaris SE pump customers. 6. As an interim measure Cardinal Health is distributing labels to be attached to the pumps. The labels advise users to ensure all programming parameters are checked before any infusion therapy is started. Labels will be sent with application instructions. 7. Cardinal Health has also produced a programming safeguards tip sheet (see Annexe 2) which includes recommendations to pump users on steps they can take to minimize unintended double key entries. Copies are available from Cardinal Health. ACTION 8. This notice should be brought to the attention of all appropriate managers, staff and users. Suggested Distribution Accident & Emergency Ambulance Services Anaesthetics Coronary Care Units Device Managers Estates/Facilities Health & Safety Hospices Intensive Therapy Units Maternity Medical Medical Physics Nursing O.D.A.s / O.D.P.s Operating Departments Risk Management Stores Supplies/Procurement Wards SCOTTISH HEALTHCARE SUPPLIES Gyle Square Edinburgh EH12 9EB A Division of the National Service Scotland for NHSScotland CONTACT iric@shs.csa.scot.nhs.uk FAX: WEBSITE: HAZ\PHAZ0621.DOC

2 HAZARD NOTICE By arrangement with the Scottish Executive Health Department ALARIS SE PUMPS (ALL MODELS): POSSIBLE OVER-INFUSION DUE TO KEYPAD ANOMALY HAZ(SC)06/21 09 OCT 2006 Page 2 of 7 Pages 9. All Alaris SE pumps (formerly the Signature Edition Infusion Pump) should be identified. Users should be advised to check the pump s settings before starting the infusion. 10. Cardinal Health should be contacted (see Enquiries) to obtain warning labels for pumps and programming safeguards tip sheets for users. 11. Once received, a warning label should be applied to every Alaris SE pump and all users should receive a copy of the programming safeguards tip sheet. ENQUIRIES Enquiries to the manufacturer and requests for warning labels / programming safeguards tip sheets, should be addressed to: Customer Services Cardinal Health The Crescent Jays Close Basingstoke RG22 4BS Tel: uk-customer-service@cardinal.com Figure 1 Alaris SE single and dual channel pumps SCOTTISH HEALTHCARE SUPPLIES Gyle Square Edinburgh EH12 9EB A Division of the National Service Scotland for NHSScotland CONTACT iric@shs.csa.scot.nhs.uk FAX: WEBSITE: HAZ\PHAZ0621.DOC

3 ANNEXE 1 09 OCT 2006 Page 3 of 7 Pages

4 ANNEXE 1 (CONT.) 09 OCT 2006 Page 4 of 7 Pages

5 ANNEXE 1 (CONT.) 09 OCT 2006 Page 5 of 7 Pages

6 ANNEXE 2 09 OCT 2006 Page 6 of 7 Pages

7 ANNEXE 2 (CONT.) HAZ(SC)06/21 09 OCT 2006 Page 7 of 7 Pages