SAFETY ACTION NOTICE By arrangement with the Scottish Executive Health Department BAXTER IPUMP, APII AND PCAII INFUSION PUMPS: DELIVERY OF UNREQUESTED PCA DOSES AND/OR AIR TO THE PATIENT SUMMARY Page 1 of 7 Pages Baxter Ipump, APII and PCAII pumps may deliver un-requested PCA doses. Additionally, Baxter Ipump and APII Infusion pumps may deliver an air bolus to the patient. The manufacturer s recommended precautions should be implemented. BACKGROUND 1. Baxter Healthcare manufactures a range of electronic infusion systems including the following: Model Product Codes Description Serial Numbers Ipump 2L3107 Pain Management System APII 2L3105 and 2L3105K Infusion Pump All PCAII 2L3104 and 2L3104R PCA Syringe Infusion Pump Table 1 2. Baxter has identified three conditions which may result in an electrical short in the PCA circuit and cause these pumps to mimic repeated pressing of the patient controlled analgesic (PCA) button. Baxter has stated that delivery of un-requested PCA doses will not exceed the programmed prescription doses. The three conditions identified are as follows: a) damaged PCA cord or button, b) partial sticking of the PCA button, c) fluid ingress into pump or PCA button. 3. There is a separate problem which affects the Ipump pain management system and APII infusion pump. Air can migrate through the silicone pumping segment of the sets and be delivered to the patient if there is an upstream occlusion. The Ipump has an upstream occlusion alarm, but this may not detect the occlusion if the flow is less than 0.5 ml/h. The APII pump does not have an upstream occlusion alarm. 4. Baxter issued three letters (see Annexes 1 to 3) in January 2006 identifying these issues and giving advice on the control of risk. ACTION 5. All implicated pumps (see Table 1) should be identified. Suggested Distribution Accident & Emergency Anaesthetics Care Home Services Dental Hospitals Device Managers District Nursing Estates/Facilities Health & Safety Health Centres Hospices Intensive Therapy Units Maternity Medical Medical Physics Nursing Oncology Operating Departments Paediatrics Pharmacy Practice Nurses Risk Management Supplies/Procurement Wards SCOTTISH HEALTHCARE SUPPLIES Gyle Square Edinburgh EH12 9EB A Division of the National Service Scotland for NHSScotland CONTACT EMAIL: iric@shs.csa.scot.nhs.uk FAX: 0131 314 0722 WEBSITE: http://www.nhsscotland.com/shs/hazards_safety/adverse_p.html N:\WORD\HAZ\FINALSAN\PUBLIC SAN\PSAN0611.DOC
SAFETY ACTION NOTICE By arrangement with the Scottish Executive Health Department BAXTER IPUMP, APII AND PCAII INFUSION PUMPS: DELIVERY OF UNREQUESTED PCA DOSES AND/OR AIR TO THE PATIENT Page 2 of 7 Pages 6. Users should be informed of these problems and advised to follow the precautions recommended by Baxter (see Annexes 2 and 3): DELIVERY OF UN-REQUESTED PCA DOSES: IPUMP, APII and PCAII (see annexe 2) 7. Prior to each use, the PCA cord should be checked to ensure it is intact and has no cuts or missing insulation. The PCA connector and the button should be checked to ensure they are securely attached to the cord. 8. If the pump displays RELEASE THE PCA BUTTON and the PCA button is not being intentionally pressed, a mechanical or electronic fault in the PCA button should be suspected. The pump and PCA cord should be removed from service immediately and placed in quarantine until repaired. 9. Liquids should not be permitted to enter the pump s casing. Particular care should be taken when cleaning the pump. Cleaning agents/solutions should not be sprayed directly onto the pump or PCA cord/button. 10. Preventative maintenance programs should ensure periodic replacement of PCA cords. DELIVERY OF AIR BOLUS: IPUMP (see annexe 3) 11. The upstream occlusion sensor of the pump should be enabled. 12. Sets containing air-eliminating filters (see Annexe 3 for product codes) should be used where: a) the occlusion sensor has been disabled or is otherwise not activated, b) infusing at flow rates below 0.5ml/hr, unless through an epidural or subcutaneous route. DELIVERY OF AIR TO THE PATIENT: APII INFUSION PUMP (see annexe 3) 13. As the APII infusion pump does not have an upstream occlusion or air sensor, sets containing aireliminating filters should be used for all delivery routes other than epidural and subcutaneous (see Annexe 3 for product codes). 14. The APII pump should not be used in circumstances where an upstream alarm is required. ENQUIRIES Enquiries to the manufacturer should be addressed to: Surecall-Baxter Medical Information, Baxter Healthcare Ltd, Wallingford Road, Compton, Newbury RG20 7QW Tel: 01635 206 345 Fax: 01635 206 071 Email: surecall@baxter.com SCOTTISH HEALTHCARE SUPPLIES Gyle Square Edinburgh EH12 9EB A Division of the National Service Scotland for NHSScotland CONTACT EMAIL: iric@shs.csa.scot.nhs.uk FAX: 0131 314 0722 WEBSITE: http://www.nhsscotland.com/shs/hazards_safety/adverse_p.html N:\WORD\HAZ\FINALSAN\PUBLIC SAN\PSAN0611.DOC
ANNEXE 1 Page 3 of 7 Pages
ANNEXE 2 Page 4 of 7 Pages
ANNEXE 2 (CONT.) Page 5 of 7 Pages
ANNEXE 3 Page 6 of 7 Pages
ANNEXE 3 (CONT.) Page 7 of 7 Pages