Events

Alerta De Seguridad para Non Flow-Stop CADD® Medication Cassette Reservoirs

Según Food and Drug Administration Philippines, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Philippines que fue producido por Smiths Medical.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Número del evento
    2018-114
  • País del evento
    Philippines
  • Fuente del evento
    FDAP
  • URL de la fuente del evento
    https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/498910-fda-advisory-no-2018-114
  • Notas / Alertas
    Data from the Philippines is current through 2019. All of the data comes from the Food and Drug Administration Philippines, 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 Philippines.
  • Notas adicionales en la data
  • Causa
    Fda advisory no. 2018-114 voluntary recall of cadd® medication cassette reservoir, part number 21-7001-24, 21-7002-24 and 21-7100-24  the food and drug administration (fda) informs the public and all healthcare concerned professionals that smiths medical manufacturer of above mentioned product with delex pharma international inc. as their distributor has voluntarily recalled certain lots of 50 and 100ml non flow-stop cadd® medication cassette reservoirs, part numbers 21-7001-24, 21-7002-24 and 21-7100-24. smiths medical informed the fda that certain non flow-stop cadd® medication cassette reservoirs, may have been manufactured with an incorrect pressure plate. when the cassette is attached to the pump, the tubing could be restricted, such that it is partially or completely occluded. the occlusion could pose risk to the patient of no delivery risk to health: the immediate impact to the patient depends on the patient condition, the therapy involved, and possibly the time to discover problem. potential health consequence due to no delivery may result in immediate or delayed effects. the severity of adverse effects, as well as the risk of long term consequences, can depend on the specific medication and the patient’s current or existing condition. the risk may occur when the clinician is not aware of the issue because the pump will continue to operate as if it is infusing medication without alarming for an occlusion. distributors, retailers, hospitals and all healthcare professionals / users are advised to discontinue further distribution, sale and use of the said affected medical device product, and coordinate with delex pharma international inc. for more information and inquiries, please e-mail us at cdrrhr_prsddthis email address is being protected from spambots. you need javascript enabled to view it. . or call us at the center for device regulation, radiation health and research (cdrrhr) hotline (02) 857-1900 local 8301. attachments: fda advisory no. 2018-114.Pdf.

Device

Non Flow-Stop CADD® Medication Cassette Reservoirs

Manufacturer

Smiths Medical