Safety Alert for volumetric infusion pump

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by B. Braun Melsungen AG || Laboratorios B. Braun S.A..

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
    I1512-541
  • Event Number
    2008EBC-0002699 y 2008EBC-0002717
  • Date
    2015-12-01
  • Event Country
  • Event Source
    INVIMA
  • Event Source URL
  • 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 an incorrect or unrealistic patient weight can be entered without activating the alarms of the medication library limit, causing a possible incorrect delivery of drugs, leading to potentially adverse events on patients.

Device

  • Model / Serial
    INFUSOMAT SPACE, PERFUSOR SPACE and PERFUSOR SPACE PCA
  • Product Description
    This equipment is used to provide solutions through epidural or intravenous routes, for diagnostic or therapeutic purposes.
  • Manufacturer

Manufacturer