Events

Safety Alert for extracorporeal circulation system for heating

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Rand S.R.L..

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
    I1705-156
  • Event Number
    2013EBC-0010835
  • Date
    2017-05-02
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=91
  • 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 informs about a possible quality problem affecting the referenced devices, which have a quick connector female and a white protective cap inside the connector, it has been detected that in some occasions the cover is a little loose and could fall accidentally, leading to that there are possible adverse events on the patient or delays in the surgical procedure.

Device

extracorporeal circulation system for heating
  • Model / Serial
  • Product Description
    The PERFORMER HT system, together with its accessories and consumables, make up an electromechanical system used to treat local hyperthermia by circulating hot fluids in the peritoneal or pleural cavity. It is particularly indicated in the following therapies: 1. Intraperitoneal or intrapleural perfusion in order to help localized hyperthermia through heated defluid circulation, which may contain chemotherapeutic drugs, in the peritoneal or pleural cavity. 2. Isolated perfusion of the organ consisting of isolating an anatomical area followed by an intra-arterial perfusion of chemotherapeutic drugs under hyperoxia / hypoxia conditions.
  • Manufacturer
    Rand S.R.L.

Manufacturer

Rand S.R.L.
  • Manufacturer Parent Company (2017)
    Rand Spa
  • Source
    NIDFSINVIMA