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| Issued: 05 October 2006 at 11:00 |
Ref: MDA/2006/058
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Immediate action |
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Action |
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Update |
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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). |
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| 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). |
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| Action by: All nursing, medical and technical staff using these devices. |
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Action:
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Distributed to:
* via CE Bulletin |
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| 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. |
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| Appendix: Manufacturer's letter. (pdf only) |
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Action deadlines for the Safety Alert Broadcast System (SABS)
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Deadline (action underway): 19 October 2006
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Deadline (action complete): 28 December 2006
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