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Medical Device Alert: Intravenous Pump Set Manufactured by Hospira (MDA/2013/081R)

This Medical Device Alert has been issued as there is a risk of embolism and allergic reaction when using intravenous pump set manufactured by Hospira.

 

Problem

Risk of embolism and allergic reaction due to exposure to particulates and non-biocompatible materials, especially during administration of parenteral lipids.

Due to a manufacturing fault, these devices may be fitted with an incorrect filter which has not undergone biocompatibility testing.

Hospira issued a Field Safety Notice (FSN) dated 22 October 2013, but has not received confirmation from enough users that they have received and acted on this information.

Action

Identify, quarantine and do not use affected product lots.

Use alternatives until new product is available from Hospira.

Liaise with Hospira for the collection of affected product.

Complete and return the reply form to Hospira.

Report any adverse incidents to Hospira and the MHRA.

 

 

 

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About The Operating Theatre Journal

The Operating Theatre Journal, OTJ, is published monthly and distributed to every hospital operating theatre department in the UK. The distribution includes both the National Health Service and the Private Sector.

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