Alerta De Seguridad para PLUM XL ™ family infusion pump, Registration No. 80253310022; Serial Numbers - Attachment

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.
ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.

According to the manifestation of the company, no complaints of health problems were identified due to the problem described above. The Spanish language is immediately displayed when the infusion pump is switched on, reading the screen or labeling. If the infusion pump is put into use and the problem is not identified prior to clinical use, attempts by health professionals to program the infusion pump without understanding instructions and other texts on the screen may lead to a programming error incorrect) or a delay in therapy.