Events

Safety Alert for PLUM XL ™ family infusion pump, Registration No. 80253310022; Serial Numbers - Attachment

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Hospira Produtos Hospitalares Ltda.; Hospira Inc..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1606
  • Date
    2015-06-09
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    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.
  • Reason
    Hospira has identified that some plum xl pumps have been marketed with software, labeling and manual in spanish.
  • Action
    The company that holds the registration in Brazil recommends that the institution notify the professionals about the notification. To correct the problem, Hospira will forward labeling and manual in Portuguese.

Device

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

Manufacturer

Hospira Produtos Hospitalares Ltda.; Hospira Inc.
  • Manufacturer Parent Company (2017)
    Pfizer
  • Source
    ANVSANVISA