The National Medicines Safety Agency (ANSM) announced that it had opened a health investigation and ordered the withdrawal of a batch of 193 nutrition bags intended for infants fed by infusion. This decision came after the death at Caen hospital on January 27 of a 2-year-old child, a few hours after the administration of an infusion bag. Since then, we have learned that a second child, fed with bags from the same lot at the Center hospitalier régional Sud-Alsace, had also died.
An inspection on the manufacturing site of the bags developed by the company Fasonut, a subsidiary of the Baxter laboratory in Strasbourg, was therefore carried out and “without presuming the origin of the deaths”, the ANSM had the incriminated bags removed. However, insists the ANSM, “according to the first elements available, this death is not linked to the administration of this bag. The health authorities are therefore continuing their investigations to identify the respective causes of these two deaths”.
This accident is a sad reminder the death of four infants in the neonatal intensive care unit of Chambéry hospital (Savoie), one year ago. The hypothesis which had been adopted for the death of the infants was “an isolated production accident which occurred on November 28 at the Marette laboratory during the preparation of the bags intended for the Chambéry hospital center” then announced the Minister of Health, Marisol Touraine .
Nutrition pouches: what do they contain?
Pocket nutrition, also called parenteral nutrition, is a nutritional assistance technique that provides the baby with all the nutrients needed by his body by infusion (a catheter is placed at the base of the neck). They are used in hospitals to feed premature, underweight or sick babies. They are also used at home for children suffering from pathologies of the intestine which do not allow them to eat normally.
The bag is changed every day and placed in an opaque packaging, because it fears the light. Monitoring (hydration, heart and respiratory rate, weight change, etc.) is necessary during parenteral feeding, to avoid any imbalance.
Pharmacies in university hospitals are equipped with pediatric parenteral preparation units that allow them to manufacture internal nutrition bags for hospitalized babies. But some hospitals use private laboratories. Until a few months ago, two laboratories were present on the French market: the Fasonut and Marette laboratories. But the latter definitively closed its doors last July for economic reasons, after having suffered the suspension of its activity for the needs of the investigation into the deaths of the babies of Chambéry. This time, it is the Fasonut laboratory which is the subject of a health investigation.
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