BodyGuard (infusional pump)

2020: A response after complaints to inadequate volumes of infusions

In the middle of March, 2020 Becton Dickinson announced a withdrawal of the infusional pumps BodyGuard developed by CME America subsidiary company after complaints to inadequate volumes of infusions. The response is characterized by the I hazard class on a scale of the Food and Drug Administration (FDA), i.e. is connected with problems, life-threatening patients.

CME America warned users about a problem still on September 6, 2019. In total 91,500 devices (number according to the A120-003XYVA directory) which were on sale in the American market during the period from October 6, 2017 to July 15, 2019 are subject to a response. All batches of the infusional pumps BodyGuard with the specified catalog number are withdrawn.

Becton Dickinson announced a withdrawal of the infusional pumps BodyGuard developed by CME America subsidiary company after complaints to inadequate volumes of infusions

The company found out that the trunk of some infusional pumps BodyGuard has big length, than define standards. Lengthening of the trunk is capable to limit a flow of drugs in the pump chamber of an infusional pump, so, leads to inadequate dosing at infusions. As a result the patient can not receive proper treatment or receive it in too light dose that can lead to serious adverse effects for health, to that number by a lethal outcome.

By March, 2020 the CME America company received three complaints to the inadequate volume of infusion and insufficient dosing of medicines. At the same time in all cases the problem was detected during testing of installation of the pump before its use on patients therefore injuries or fatal cases it was not announced. It does not exclude existence of undetected incidents.

Earlier the company suggested clients to refuse the rejected infusional sets and recommended to announce all adverse phenomena in the FDA MedWatch program for monitoring of ghost effects.^[1]

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