Events

Safety Alert for equipment and accessories for cardiac monitoring

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Hospira Costa Rica Ltd || ICU Medical Inc Salt Lake City || ICU Medical De México S. A. C. V..

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
    R1611-517
  • Event Number
    2009DM-0004837
  • Date
    2016-11-16
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=114
  • 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 received reports about delays in some of the referenced devices, which could potentially introduce small amounts of air in the line, leading to the occurrence of adverse events in patients.

Device

equipment and accessories for cardiac monitoring
  • Model / Serial
    Concerning monitoring kits with Transpac IV transducers, references and specific batches.
  • Product Description
    Invasive medical devices to determine the cardiovascular pressure of the patient and some hemodynamics: PVC (central venous pressure) PAPA (pulmonary arterial pressure), PCP (pulmonary capillary pressure), PAS (systemic arterial pressure), PVI (left ventricular pressure), PAI (pressure left atrial) and PA (blood pressure and supply of intravenous solutions required in these processes).
  • Manufacturer
    Hospira Costa Rica Ltd || ICU Medical Inc Salt Lake City || ICU Medical De México S. A. C. V.

Manufacturer

Hospira Costa Rica Ltd || ICU Medical Inc Salt Lake City || ICU Medical De México S. A. C. V.
  • Manufacturer Parent Company (2017)
    Pfizer
  • Source
    NIDFSINVIMA