Field Safety Notices about ROTEM® delta Thromboelastometry System

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
  • Event Country
  • Event Source
  • 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
    Internal and external observations with some vials of r ex-tem, lot 21734044 (expiration 10/2017) demonstrated prolonged ct values. in testing, some whole blood patient samples have shown ct values up to 4 times longer than expected. qc measurements with rotrol n or p have also produced longer ct’s as compared to other lots; these ct values have at times exceeded the target ranges. all other parameters and functions such as heparin neutralization or sensitivity to factor deficiencies remain unaffected. while the root cause of these observations is currently under investigation, we have taken the decision to recall this lot. .