Events

Safety Alert for INFUSION PUMP LIFECARE PLUM A + (Registro Anvisa: 80253310023).

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

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
    1051
  • Date
    2011-03-11
  • 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 record holder, the problem is related to improper mounting of the buzzer on one of the electronic boards of the pumps. The problem was identified through reports of alarm failure reported by users of the pumps, sent globally to the company. Hospira identified an incidence less than 1 (one) reported failure per million infusions, based on these reports.
  • Reason
    Possibility of failure of the sound alarm of the equipment.
  • Action
    The registry holder has informed that it will communicate to clients a sound alarm test methodology, to verify the problem. The solution to the problem is still being developed by the company. If you have this infusion pump in your inventory and you have verified problems with this product, or if you want to clarify your doubts with Hospira Produtos Hospitalares Ltda., Use the phone number 0800-7733-133.

Device

INFUSION PUMP LIFECARE PLUM A + (Registro Anvisa: 80253310023).

Manufacturer

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