MDA/2008/005 - Hard-shell venous reservoirs and oxygenators used for cardiopulmonary bypass during heart surgery: various manufacturers

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Problem:

1. A bolus of air was forced up the venous line to the heart when a quick-prime line was misconnected to the vent port of a hard-shell venous reservoir.
2. A problem with a vaporiser prevented the oxygen supply reaching the oxygenator.

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Action:

• Incorporate checking of the hard-shell venous reservoir vent port and correct functioning of the oxygen supply in the pre-bypass check procedure.
• Ensure that a pressure relief valve is always used with hard-shell venous reservoirs.
• Ensure that the standards of monitoring recommended by the Society of Clinical Perfusion Scientists of Great Britain and Ireland (SOPGBI) are always undertaken for heart lung bypass procedures. (Available on the MHRA website www.mhra.gov.uk)
• Ensure an alternative oxygen supply is always available for cardiopulmonary bypass (e.g. an oxygen cylinder with appropriate regulator, flow meter and tubing, which must be checked as functioning correctly and containing an adequate supply). NOTE: These actions have been endorsed by the SOPGBI.

Distributed to:

* via CE Bulletin

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