FLO-GARD VOLUMETRIC INFUSION PUMP. MODELS 6200, 6201, 6300 AND 6301 .. RISK CLASS III. 의 안전성 경고

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

Baxter Hospital Ltda informs that the risks associated with absence of alarm when occlusion occurs above the flexible chamber of the infusion pump are: the return flow of the patient's blood, the loss of the infusion line or the non-administration of the drug to the patient. Still according to Baxter, the conditions that may potentially cause these situations are as follows: (1) when the vial or pouch has been emptied, but the pump continues to pump; (2) when the spike was not completely inserted into the bottle or pouch; (3) when a rigid bottle (glass bottle, for example) or semi-rigid bottle (Buretrol, for example) is improperly vented. In these cases, according to the addendum to the manual, specific prevention measures should be observed. Anvisa's Technovigilance Unit is monitoring this case.