Events

Safety Alert for System for Fluid Heating RANGER 245

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by 3M Health Care.

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
    I1510-485
  • Event Number
    2010DM-0005465
  • Date
    2015-10-29
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=169
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • Extra notes in the data
  • Reason
    The manufacturer states that the operation of the medical device can be affected by the close use of finger-way radios, causing the activation of an audible and visual alarm of high or low temperature or the unstable operation thereof, leading to the occurrence of adverse events or delays in the patient care.

Device

System for Fluid Heating RANGER 245
  • Model / Serial
    RANGER 245
  • Product Description
    The RANGER heating system is designed to heat blood, blood products and liquids. The heating system for blood and fluids RANGER is a device composed of a heating unit and a disposable equipment for the administration of blood and fluids intravenously (IV), the heating system RANGER is designed to heat blood, blood products and liquids and achieves a speed of MVA flow rate at 500ml per minute. Two disposable equipment for blood and fluids can be obtained: one for normal flow applications and one for high flow applications. These disposable equipment, designed for use in reusable dewaxing units, are sterilized, do not contain latex and are for single use only.
  • Manufacturer
    3M Health Care

Manufacturer

3M Health Care
  • Manufacturer Parent Company (2017)
    3m Company
  • Source
    NIDFSINVIMA