Events

Safety Alert for bags for collection and blood infusion

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Fresenius Kabi Ag || Fresenius Kabi (Guangzhou) Co., Ltd. || Fresenius Hemocare C.Z. S.R.O || Fresenius Hemocare Brasil Ltda. || Fresenius Hemocare Austria Gmbh || Fresenius Hemocare Netherlands B.V.

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
    R1703-97
  • Event Number
    2009DM-0004196
  • Date
    2017-03-13
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=97
  • 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 reports that the bags have presented dehongos growth on the label of the primary packaging, however it clarifies that the sterility of the product is not compromised, leading to the occurrence of potentially adverse events on the patients.

Device

bags for collection and blood infusion
  • Model / Serial
  • Product Description
    Conventional bags and TOP AND BOTTOM equipment for collection, processing, leucorreduction and infusion of whole blood, red blood cells, fresh frozen plasma, platelet concentrate and cryoprecipitate. It comes with cpda-1 or CPD anticoagulant and SAGmanitol as a preservative solution. In conventional presentation of simple equipment (whole blood); double (red blood cells and plasma) triple (red blood cells, plasma and platelets) and quadruple (red blood cells, plasma, platelets and cryoprecipitate) and transfer. TOP ANDBOTTOM for leucorreduction in triple presentation (red blood cells, plasma) quadruple (red blood cells, plasma, platelets) and quintuple (red blood cells, plasma, platelets). Collection capacity 450 ml +/- 45 ml of blood. The bags serve for infusion of blood or its components.
  • Manufacturer
    Fresenius Kabi Ag || Fresenius Kabi (Guangzhou) Co., Ltd. || Fresenius Hemocare C.Z. S.R.O || Fresenius Hemocare Brasil Ltda. || Fresenius Hemocare Austria Gmbh || Fresenius Hemocare Netherlands B.V

Manufacturer

Fresenius Kabi Ag || Fresenius Kabi (Guangzhou) Co., Ltd. || Fresenius Hemocare C.Z. S.R.O || Fre...