Events

Avis De Sécurité sur HD Conventional Lines

Selon ALIMS (Agencija za lekove i medicinska sredstva), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Serbia qui a été fabriqué par BAXTER HEALTHCARE.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Date
    2017-12-28
  • Date de publication de l'événement
    2018-01-29
  • Pays de l'événement
    Serbia
  • Source de l'événement
    ALIMSA
  • URL de la source de l'événement
    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 / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
    1701, 1706, 1711, 1712, 1715
  • Manufacturer
    BAXTER HEALTHCARE

Manufacturer

BAXTER HEALTHCARE