Events

Safety Alert for Ipump Patient-Controlled Infusion Pump. Distributed units in the US and Canada, Europe, New Zealand and Singapore

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Baxter Healthcare Corp.

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
    375
  • Date
    2001-12-30
  • 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.
  • Extra notes in the data
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    An ecri member hospital reported that when one of the above pumps in its inventory was turned off (turned off) and then (reactivated) reclosed in the same patient, the pump returned the patient's original prescription instead of adjustments made during therapy. the problem has occurred on many occasions and has led to the highest medication for the patient.
  • Action
    ECRI states that the user has two options when turning the Ipump infusion pump back on: (1) they can clean the pump and reprogram it to the next patient, or (2) they can use the "Previous Prescription" function? ¿(Previous RX? ¿) To reverse the originally programmed pump prescription. ANVISA and ECRI recommend the following: (1) to alert all staff who program the Baxter Ipump infusion pump of this problem and notify ANVISA. Explain to the team how the function "Previous RX" works. (2) Instruct the staff clearly about all current settings (operation) before the Ipump infusion pump is deactivated during therapy. When the pump is activated back (again), the team must reprogram it with these settings and confirm these settings before resuming therapy. For more information, contact the ANVISA Technovigilance Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485.

Device

Ipump Patient-Controlled Infusion Pump. Distributed units in the US and Canada, Europe, New Zeala...

Manufacturer

Baxter Healthcare Corp
  • Source
    ANVSANVISA