MDA/2008/080 - Enteral feeding pump - ClearStar model M771 manufactured by Abbott Nutrition

Device:
Enteral feeding pump. ClearStar model M771 manufactured by Abbott Nutrition. Specific serial numbers.

Problem:
Risk of under-infusion due to cracking/breaking of an internal adapter bracket.

Following an initial service programme of these pumps in 2007 (see MDA/2007/060), Abbott has identified another 298 pumps that may be affected. Abbott is running a second service programme but is unable to locate 38 of these pumps (serial numbers listed in the appendix (629Kb)).

Action by:
All staff responsible for prescribing and maintaining enteral feeding devices, particularly dietetic departments and EBME departments.

Action:

• Check the list of serial numbers in the appendix. Contact Abbott to arrange exchange if the pump is listed.
• Ensure that users are aware of the manufacturer's customer notice. Where the location of the pump is known to Abbott, its customers will be contacted by Abbott (see appendix).

Distributed to:

* via CE Bulletin 

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Contacts:
Details of manufacturer contacts and contacts for technical and clinical aspects.

Change of address or removal from address list for CSCI and Healthcare Commission.

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Appendix:
Abbott Nutrition customer notice and list of serial number of pumps where location is unknown.

PDF Only (629Kb)