Events

Field Safety Notices about cartridges ROTEM® sigma complete

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Tem Innovations GmbH.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2016-03-11
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    We must inform you that the current lots of cartridges rotem® sigma complete (art. no. 555501) and cartridges rotem® sigma complete + hep (art. no. 555502) do not ionger consistently fulfi ll the requirement of neutralizing heparin up to 3 lu ufh /m l whole blood as indicated in the package insert. whole blood samples containing heparin will show unexpected increased ct-values and decreased amplitudes in the tests extem c, aptem c and fibtem c. .

Device

cartridges ROTEM® sigma complete
  • Model / Serial
    Art. No. 555501: Iot KS150602 (exp. date: 31.03.2016) Iot KS150701 (exp. date: 30.04.2016) Iot KS150801 (exp. date: 31.05.2016) Iot KS151003 (exp. date: 31.07.2016) Art. No. 555502: Iot KS150603 (exp. date: 31.03.2016) Iot KS 150703 ( exp. date: 30.04.2016) Iot KS150802 (exp. date: 31.05.2016) Iot KS151201 (exp. date: 30.09.2016)
  • Manufacturer
    Tem Innovations GmbH

Manufacturer

Tem Innovations GmbH