Events

Safety Alert for analyzer for electrolytes and arterial gases

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Siemens Healthcare Diagnostics Manufacturing Ltd. || Siemens Healthcare Diagnostics 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
    I1501-16
  • Event Number
    2009DM-0004077
  • Date
    2015-01-13
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=188
  • 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 the value resulting from the neonatal weakening factor (nbili) may be affected under specific conditions of equipment operation, leading to potential adverse events for patients.

Device

analyzer for electrolytes and arterial gases
  • Model / Serial
    Model RAPIDLAB 1245, RAPIDLAB 1265, RAPIDPOINT 405 and RAPIDPOINT 500, specific serials.
  • Product Description
    The RAPIDPOINT® 400/405 instruments are analyzers for electrolyte and arterial gas tests at the patient's bedside by electrochemistry. Use samples of blood or capillary. It reports the values of PH, PCO2, PO2, HCO3-, CTCO2; CO-OXI, BE (ECF), O2SAT, O2CT, PO2 (AA), PO2 (A / A), FO2HB, FMETHB and FCOHB for gasessanguineal and electrolyte analysis NA +, K +, CA ++, CL-, LI +, Glucose, Lactate , HCT and HB. It is in a system designed for critical patients in surgery, uci and emergencies that report the values of the tests and communicates the declinical results of the patient. The reagents that are used with the RAPIDPOINT® equipment have respective health records.
  • Manufacturer
    Siemens Healthcare Diagnostics Manufacturing Ltd. || Siemens Healthcare Diagnostics Inc.

Manufacturer

Siemens Healthcare Diagnostics Manufacturing Ltd. || Siemens Healthcare Diagnostics Inc.
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    NIDFSINVIMA