Events

Field Safety Notices about HD Conventional Lines

According to ALIMS (Agencija za lekove i medicinska sredstva), this field safety notices involved a device in Serbia that was produced by BAXTER HEALTHCARE.

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
    2017-12-28
  • Event Date Posted
    2018-01-29
  • Event Country
    Serbia
  • Event Source
    ALIMSA
  • Event Source URL
    https://www.alims.gov.rs/latin/2018/01/29/obavestenje-o-meri-povlacenja-sa-trzista-medicinskog-sredstva-gambro-lines-for-hemodialysis-tip-blood-tubing-sets-model-bl-105-krvna-linija-za-hemodijalizu-set/
  • Notes / Alerts
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), 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 Serbia.
  • Extra notes in the data
  • Reason
    The manufacturer has recently received a number of complaints from users regarding "hd conventional lines" due to the sudden bursting of the pre-dialysis artery expansion chamber during various stages of treatment. after investigation, the manufacturer concluded that variations in the formulation of the material occurred, which could lead to increased material brittleness and reduced impact resistance. risk of cracking of the pre-dialysis arterial expansion chamber may lead to blood spatter. failure to detect this can lead to serious blood loss. also, this phenomenon poses a biological risk to third parties.

Device

HD Conventional Lines

Manufacturer

BAXTER HEALTHCARE