Events

Safety Alert for pump for enteral nutrition

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Fresenius Kabi AG.

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
    I1407-286
  • Event Number
    2014EBC-0011079
  • Date
    2014-07-14
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=200
  • 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 reports that it has detected a potential risk for damage to the charger, which can be separated and leave the electronic components exposed, causing possible electric shocks, which can lead to adverse events on the patient or user.

Device

pump for enteral nutrition
  • Model / Serial
    AMIKA references Z044110, serials before 00019160
  • Product Description
    This device is a peristaltic pump specialized in enteral nutrition. It is used to administer a volume of nutrition to a programmed flow to the patient (human solos). It is designed to administer fluids through nasogastric or percutaneous gastrostomy feeding tubes, and to administer any type of fluid enteral malnutrition; for example: drinking water (with or without gas), tea, soft drinks, fresh water and the full range of products prepared from FRESENIUS KABI. This pump can be used on one patient at a time and on multiple patients during its lifetime.
  • Manufacturer
    Fresenius Kabi AG

Manufacturer

Fresenius Kabi AG