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 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
    Recall / Field Safety Notice
  • ID de l'événement
    mdprc 083 04 12 001
  • Date de mise en oeuvre de l'événement
    2013-05-12
  • 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=3594
  • 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
    Baxter would like to inform you that an error in the sequence of instructions in the direction inserts for the products listed above has been identified. in section 1 (set placement on cycler) under directions for use, step 1.3 instructs users to remove the protector from the patient line connector on the set prior to connecting solution bags. users should not remove the protector from the patient line connector on the set prior to connecting solution bags. the tip protector should be removed from the patient line connector after priming and immediately prior to connecting the patient line to the transfer set, as described in the in the homechoice and homechoice pro apd systems patient at-home guide. exposure of the patient line during setup can lead to touch contamination resulting in the potential for developing peritonitis. baxter is in the process of updating the direction inserts with the correct sequence of instructions.

Device

Disposable Set Tubing, HomeChoice Disposable Sets
  • Modèle / numéro de série
    (1) R5C4478 HomeChoice Automated PO Set with Cassette 8-Prong; (2) R5C4479 HomeChoice Automated PO Set with Cassette 4-Prong . update code from MHRA HomeChoice disposable sets: R5C4455, R5C4478,R5C4479, R5C4479E see the attachment.
  • Description du dispositif
    Disposable Set Tubing
  • Manufacturer
    Baxter Healthcare

Manufacturer

Baxter Healthcare
  • Société-mère du fabricant (2017)
    Baxter International
  • Représentant du fabricant
    Arabian Health Care Supply Co. (AHCSC), Riyadh (01) 4747444
  • Source
    SFDA