Events

Field Safety Notices about Medrad® Intego PET Infusion 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 Bayer Medical Care.

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
  • 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
    Our investigation indicates that the inner diameter of the saline tubing is out of specification and may result in the system failing to position the dose correctly during extraction, potentially leading to a low measurement of the extracted dose or to a higher dose being extracted. the occluded sas tubing may impair the priming function and prompt an “rp prime failed. check sas and vial installation, then reprime.” error message. .

Device

Medrad® Intego PET Infusion System
  • Model / Serial
    50856405 50886468 50857510 50886469 50860994 50888285 50866789 50888286 50867921 50888287 50869464 50888288 50869465 50888373 50871131 50890483 50872965 50890484 50878229 50890485 50878230 50892357 50878231 50892358 50878232 50892359 50881328 50892360 50881393 60000321 50881394 60000322 50881395 60000323 50881506 60000692 50881511 60000789 50881512 60000790 50882753 60000833 50886316 60000834 50886467 60000835
  • Manufacturer
    Bayer Medical Care

Manufacturer

Bayer Medical Care
  • Manufacturer Parent Company (2017)
    Bayer AG
  • Source
    AMPMDRS