Fresenius Kabi Applix Smart pump - Health Facilities Scotland
Fresenius Kabi Applix Smart pump - Health Facilities Scotland
Fresenius Kabi Applix Smart pump - Health Facilities Scotland
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SAFETY ACTION NOTICE<br />
By arrangement with the Scottish Government <strong>Health</strong> Directorates<br />
FRESENIUS KABI APPLIX SMART PUMP:<br />
RISK OF FREE-FLOW IF GIVING SET INCORRECTLY FITTED<br />
SUMMARY<br />
SAN(SC)07/61<br />
21 DEC 2007<br />
Medical Devices<br />
Page 1 of 2 Pages<br />
Incorrectly fitted giving sets on <strong>Fresenius</strong> <strong>Kabi</strong> <strong>Applix</strong> <strong>Smart</strong> enteral feeding <strong>pump</strong>s can permit free<br />
flow of feed to the patient and could result in fatal over-feeding. Precautions are recommended.<br />
BACKGROUND<br />
1. <strong>Fresenius</strong> <strong>Kabi</strong> Ltd manufactures a range of enteral feeding <strong>pump</strong>s including the <strong>Applix</strong> <strong>Smart</strong><br />
<strong>pump</strong>. It has been reported that some patients received fatal gross over-feeds from these <strong>pump</strong>s.<br />
2. Although no faults were found with the <strong>pump</strong>s it was found that similar conditions could be<br />
simulated if the giving set was incorrectly fitted. An incorrectly fitted giving set can allow free<br />
flow of the feed through the <strong>pump</strong> directly to the patient.<br />
3. The manufacturer has given explicit guidance in the Instructions For Use (IFU) regarding the<br />
fitting of the giving set. Supplementary instructions for fitting giving sets are provided (see Figure<br />
1, page 2) showing correct and incorrect configurations.<br />
4. It should be noted that over-feeding is possible with other makes of feeding <strong>pump</strong>s if the giving<br />
sets are not fitted correctly.<br />
ACTION<br />
5. This notice should be brought to the attention of all appropriate managers, staff and users.<br />
6. Users of <strong>Fresenius</strong> <strong>Kabi</strong> <strong>Applix</strong> <strong>Smart</strong> enteral feeding <strong>pump</strong>s should ensure that the giving set is<br />
correctly fitted in accordance with the manufacturer’s IFU and supplementary instructions (see<br />
Figure 1, page 2)<br />
7. The manufacturer’s IFU should be available to users and staff at all times and users should adhere<br />
to the guidance provided by the manufacturer.<br />
8. All users should be adequately trained and assessed prior to using of this type of device. Users’<br />
competency in using this device should be regularly assessed.<br />
9. Visual checks that the device is functioning correctly should be made and recorded by users before<br />
leaving the device unattended.<br />
Suggested Distribution Care Home Teams Community Care Device Managers<br />
Dietetics District Nursing Hospices Intensive Therapy Units<br />
Loaned Equipment Stores Medical Medical Physics Nursing<br />
Nutrition Nurses Oncology Pharmacy Risk Management<br />
Special Care Baby Units Stores Wards<br />
SCOTTISH HEALTHCARE SUPPLIES<br />
Gyle Square Edinburgh EH12 9EB<br />
A Division of the National Service <strong>Scotland</strong> for NHS<strong>Scotland</strong><br />
CONTACT EMAIL: iric@shs.csa.scot.nhs.uk FAX: 0131 314 0722<br />
WEBSITE: http://www.nhsscotland.com/shs/hazards_safety/adverse_p.html N:\WORD\HAZ\IRIC PUBLICATIONS\FINAL SAN\PUBLIC SAN\PSAN0761.DOC
SAFETY ACTION NOTICE<br />
By arrangement with the Scottish Government <strong>Health</strong> Directorates<br />
FRESENIUS KABI APPLIX SMART PUMP:<br />
RISK OF FREE-FLOW IF GIVING SET INCORRECTLY FITTED<br />
ENQUIRIES<br />
Enquiries to the manufacturer should be addressed to:<br />
Adrian Percival<br />
<strong>Fresenius</strong> <strong>Kabi</strong> Ltd<br />
Cestrian Court<br />
Eastgate Way<br />
Runcorn<br />
Cheshire WA7 1NT<br />
Tel: 01928 533 454<br />
F ax: 01928 533 587<br />
E-mail: adrian.percival@fresenius-kabi.com<br />
Figure 1<br />
SCOTTISH HEALTHCARE SUPPLIES<br />
Gyle Square Edinburgh EH12 9EB<br />
A Division of the National Service <strong>Scotland</strong> for NHS<strong>Scotland</strong><br />
SAN(SC)07/61<br />
21 DEC 2007<br />
Medical Devices<br />
Page 2 of 2 Pages<br />
CONTACT EMAIL: iric@shs.csa.scot.nhs.uk FAX: 0131 314 0722<br />
WEBSITE: http://www.nhsscotland.com/shs/hazards_safety/adverse_p.html N:\WORD\HAZ\IRIC PUBLICATIONS\FINAL SAN\PUBLIC SAN\PSAN0761.DOC
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