Volumat MC Agilia (infusional pump)

2019: A response infusional pumps which kill

At the beginning of July, 2019 Fresenius Kabi voluntarily withdraws infusional pumps of Volumat MC Agilia and software of Vigilant Drug'Lib. The company wishes to correct software failures which already led to the death of one patient.

According to the website of the company, Volumat MC Agilia is the small portable infusional pump held for use in several hospital premises. Vigilant Drug’Lib Agilia is software for correction of a dose of medicine, configured locally. The company revealed four errors softwares which can change the volume of infuziruyemy liquid or medicine that in rare instances can lead to serious injuries or the death of the patient. Regulatory bodies were notified on the response undertaken by the company, but did not begin to classify threat in terms of potential harm for patients.

Infusional pump of Volumat MC Agili

In addition to error correction, Fresenius Kabi is going to upgrade a signal of completion of infusion. Representatives of the company consider that high-priority signaling is suitable for informing doctors on the end of a procedure better. The signal given in time will help to prevent serious injuries or the death of the patient at other faults.

Outside the USA it was announced one death connected with fault of an infusional pump. The patient died from overdose of noradrenaline as the doctor did not adjust infusion volume after change of an infusional packet and did not notice an alarm signal of a pump. Fresenius Kabi intends to update software on all devices which will come to the service center of the company. The company notified all other clients by the special letter with the recommended remedial measures.

Warning concerns an infusional pump of Volumat MC Agilia with versions of software 1.7 and 1.9a (a product code: Z021135) and versions 1.0 and 1.1 Vigilant Drug'Lib (product code: Z073476).^[1]

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