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
    I1508-361
  • Event Number
    2014EBC-0011258
  • Date
    2015-08-04
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=174
  • 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 notifies that when using the bolus epidural infusion mode, the amount of medication delivered may be greater than the programmed one, when catheters with larger internal diameter are used than to adjust the flow precision of the pump (gauge <20), leading to present potentially adverse events on the patient.

Device

Infusion Pump SAPPHIRE
  • Model / Serial
    SAPPHIRE serial 163111301, 16311303, 163113601, 163116501, 163121301, 163121303, 163123601 and || 163126501
  • 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