Events

Safety Alert for system for intraoperative blood autotransfusion Haemonetics

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Haemonetics Corporation || Haemonetics (Uk) Ltd. || Haemonetics México Manufacturing || Haemonetics Corporation || Sanmina-Sci Systems (Malaysia) Sdn Bhd || Haemonetics Manufacturing 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
    I1604-160
  • Event Number
    2009EBC-0003419
  • Date
    2016-04-18
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=146
  • 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 identified that the outer diameter of the base in the referenced devices does not fit inside the mandrel of the centrifuge, which can cause noise, lift the container in the centrifuge and in some cases, break the container, which could lead to potential adverse events on users and loss of blood component are potentially present.

Device

system for intraoperative blood autotransfusion Haemonetics

Manufacturer

Haemonetics Corporation || Haemonetics (Uk) Ltd. || Haemonetics México Manufacturing || Haemoneti...
  • Source
    NIDFSINVIMA