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"The rupture of a flow regulator at the base of the clamp was observed during parenteral nutrition" Cherpin et al (2021).

IV drip flow regulator damage

Abstract:

Flow regulators are widely used in hospitals to assist with intravenous (IV) infusion of medication. The rupture of a flow regulator at the base of the clamp was observed during parenteral nutrition. This rupture resulted in fluid leakage and an inlet of air, responsible for an air embolism in a fragile patient who had undergone a bilateral lung transplant. The patient’s clinical condition required him to be transferred to a continuous monitoring unit. A serious Adverse Event in Healthcare (AEH) was reported, as well as a medical device vigilance report. A Feedback Committee (FC) was set up and it recommended an audit within the health care departments to study the conditions for use of flow regulators and to propose corrective actions. Despite the technical data sheet of the device not recommending the administration of lipid emulsions and glucose solutions above 10%, the manufacturer’s expert report concluded that the mechanical failure could not be linked to the type of solution. However, the audit did reveal a lack of knowledge of certain rules for using this device. The analysis of this AEH is part of the establishment’s patient safety procedure. The AEH highlighted a deviation in care concerning the conditions for use of flow regulators, thus resulting in misuse. The collaboration between the various actors involved in the analysis of this AEH led to the implementation of improvement actions on the root causes, related to the lack of information and of training for professionals on correct use of the medical device.

Reference:

Cherpin A, Peyron F, Desmazes-Dufeu N, Ragni E, Lassale B, Bues-Charbit M. Concerning one case of rupture of a flow regulator: How patient safety procedures contribute to the correct use of medical devices. Pharmazie. 2021 Dec 5;76(12):618-624. doi: 10.1691/ph.2021/1752. PMID: 34986960.