Events

translation missing: fr.activerecord.attributes.event.titles.recall_field_safety_notice

Selon Saudi Food & Drug Authority, ce/cet/cette translation missing: fr.activerecord.attributes.event.types.recall_field_safety_notice concerne un dispositif en/au/aux/à Saudi Arabia qui a été fabriqué par Sorin.

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
    Recall / Field Safety Notice
  • ID de l'événement
    mdprc 086 03 17 001
  • Date de mise en oeuvre de l'événement
    2017-05-18
  • Pays de l'événement
    Saudi Arabia
  • Source de l'événement
    SFDA
  • URL de la source de l'événement
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=11073
  • Notes / Alertes
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • Notes supplémentaires dans les données
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Cause
    Heater-cooler devices known or suspected to be contaminated with m. chimaera, based on the facility’s testing program or other information known to the hospital, should be removed from the operating room or, if feasible, from service as soon as is practicable. we recommend contacting your livanova representative to assess cleaning options prior to further use. 2. for facilities who have devices that are not known to be contaminated with m. chimaera, we recommend the following actions: following the operating instructions for heater-cooler devices and specifically those relating to cleaning and disinfecting. we continue to believe that following these operating instructions is essential to mitigating the potential risk posed by using these non-sterile devices. b. if appropriate for your operating room, direct or channel the heater-cooler exhaust away from the patient, e.G., to the operating room exhaust vent per the field safety notice “cardiac surgery mycobacterium risks c. conducting water quality monitoring per the field safety notice “cardiac surgery mycobacterium risks. d. using new accessories, tubing, and connectors to prevent recontamination when using a different heater-cooler device. be aware that device contamination also may occur from other sources such as environmental contamination or device contact with contaminated accessories.

Device

Sorin Group perfusion system – Heater-cooler 1T, Heater-cooler 3T and FlexTherm devices
  • Modèle / numéro de série
    Catalog number: 16-02-50, 16-02-80, 16-02-81, 16-02-82, 16-02-83, 16-02-85, 16-02-95, 16-70-00
  • Description du dispositif
    Warming/Cooling Units, Patient
  • Manufacturer
    Sorin

Manufacturer

Sorin
  • Société-mère du fabricant (2017)
    LivaNova PLC
  • Représentant du fabricant
    Arabian Trade House Est.
  • Source
    SFDA