Events

Safety Alert for Infusion Pump SAPPHIRE

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

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
    I1606-242
  • Event Number
    2014EBC-0011258
  • Date
    2016-06-09
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=137
  • 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 states that it has identified a problem with the current air detection method in the tube with the unique combination of opacity and infrared absorption, where in a specific range for iron sucrose concentrations a signal recognized by the algorithm could be emitted. as detection of air in the tube, resulting in a false alarm "air in piping", which can lead to conferments for users and potentially serious adverse events on the patient.

Device

Infusion Pump SAPPHIRE
  • Model / Serial
    Sapphire Epidural / 163122901 and 163982901
  • Product Description
    Delivery controlled through intravascular, subcutaneous, intraarterial and epidural routes. The pump is designed to deliver saline sera, total parenteral nutrition (TPN), lipids, IV medicine, epidural medication, blood and blood products. The SAPPIHRE pump includes the following infusion modes for all intended uses: continuous, intermittent, TPN, PCA, multi-step and epidural. Labomba is indicated to be used both by health professionals in a clinical environment and by home users in an ambulatory environment. The SAPPHIRE pump is designed to follow the patient through the various areas of care and is suitable for use in different configurations
  • Manufacturer
    Q Core Medical Ltd

Manufacturer

Q Core Medical Ltd