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 106 03 15 000
  • Date de mise en oeuvre de l'événement
    2015-03-29
  • 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=7368
  • 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 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
  • Modèle / numéro de série
    Product Codes: 5C4471, 5C4474, 5C8310, R5C8320. (Only codes 5C831 0 and R5C8320 are being distributed is Saudi Arabia)
  • Description du dispositif
    HomeChoice & HomeChoice Pro
  • 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