Events

Safety Alert for Infusion pump CADD

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Smiths Medical Asd, 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
    I1605-216
  • Event Number
    2015EBC-0013709
  • Date
    2016-05-24
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=139
  • 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 has detected that when using the referenced medical devices, a lower infusion rate than the programmed one can be presented, resulting in insufficient therapy, which could lead to the potential occurrence of adverse events on the patients.

Device

Infusion pump CADD
  • Model / Serial
    Administration Set references 21-7321-24, 21-7322-24, 21-7323-24, 21-7324-24, 21-7333-24, || 21-7336-24, 21-7339-24, 21-7359-24, 21-7383-24, 21-7390- || 24, 21-7391-24, 21-7394-24 and 21-7395-24, dated || expiration equal to or before March 2021.
  • Product Description
    The CADD SOLIS ambulatory infusion pump system provides a pharmacotherapy measured in patients in hospital and outpatient areas. The ambulatory infusion pump CADD SOLIS is indicated for intravenous infusion, intra-arterial, subcutaneous, intraperitoneal, near the nerves, in an intraoperative site (soft tissues, site of the body cavity / surgical wound) and the epidural or subarachnoid spaces. The pump is designed for techniques that require a continuous rate of infusion and / or intermittent unbolo and / or on demand doses controlled by the patient.
  • Manufacturer
    Smiths Medical Asd, Inc.

Manufacturer

Smiths Medical Asd, Inc.