Events

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

Según Saudi Food & Drug Authority, este evento ( translation missing: es.activerecord.attributes.event.types.recall_field_safety_notice ) involucró a un dispositivo médico en Saudi Arabia que fue producido por Baxter Healthcare.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 106 03 15 000
  • Fecha de inicio del evento
    2015-03-29
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=7368
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    Baxter healthcare is sending this communication to inform you of errors found in the arabic version of the instructions for use 'homechoice patient at home guide (pahg)' document number 071964016ara-sa, rev.C. the manual was intended to support saudi arabia's need to provide instructions for use on the following homechoice devices which have been distributed in saudi-arabia: - product codes r5c8320, 5c4474 - ce marked and for use with 230 v power supply (product code 5c4474 devices manufactured on or after 26 june 2013, serial numbers 650905 and onwards, were no longer ce marked). - product codes 5c4471, 5c8310 - non-ce marked and for use with 115 v power supply. the following errors were identified: 1) on the second page, it is not specified which product codes are ce marked and which codes are not. 2) on page 235, under electrical power requirements, the power requirements for the 115v configurations have been omitted. the correct supply voltage is mentioned on the labeling on the dataplate of the device, however, that label is in english and might not be understood by a patient using the device. 3) on the page 235 product codes r5c8320 and 5c8310 were incorrectly listed as "r5c8310" and "5c8320". a patient/user may erroneously plug a 115v device into a 230v outlet. this may cause the fuse within the homechoice device to blow rendering the device unusable. this may subsequently result in a slight delay in therapy as patients are able to continue therapy with manual supplies. most patients can also contact their pd centers or technical service for a swap within 24 hour.

Device

HomeChoice & HomeChoice Pro
  • Modelo / Serial
    Product Codes: 5C4471, 5C4474, 5C8310, R5C8320. (Only codes 5C831 0 and R5C8320 are being distributed is Saudi Arabia)
  • Descripción del producto
    HomeChoice & HomeChoice Pro
  • Manufacturer
    Baxter Healthcare

Manufacturer

Baxter Healthcare
  • Empresa matriz del fabricante (2017)
    Baxter International
  • Representante del fabricante
    Arabian Health Care Supply Co. (AHCSC), Riyadh (01) 4747444
  • Source
    SFDA