Events

Safety Alert for Infusion pump Graseby

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Smiths Medical Md, Inc.

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
    R1710-461
  • Event Number
    2009EBC-0004058
  • Date
    2017-10-02
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=71
  • 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 been able to identify that in some cases the lock and key provided with the referenced equipment does not correspond to the standard key, the affected equipment was manufactured or revised between october 30, 2015 and april 6, 2016, the key provided allows to close and open but can not be shared between the different affected pumps and the others as it should happen, this key is necessary to unlock the safety box and be able to program an infusion, change or restart an infusion that has been interrupted, leading to possible delays in procedures or adverse events. the patients.

Device

Infusion pump Graseby
  • Model / Serial
    3300, concerning the accessories of the 3000 GRASEBY series
  • Product Description
    Indicated for infusion in the intravenous, intraarterial, subcutaneous, intraperitoneal, epidural or subarachnoid space.
  • Manufacturer
    Smiths Medical Md, Inc

Manufacturer

Smiths Medical Md, Inc