Events

Alerte De Sécurité sur Non Flow-Stop CADD® Medication Cassette Reservoirs

Selon Food and Drug Administration Philippines, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Philippines qui a été fabriqué par Smiths Medical.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Numéro de l'événement
    2018-114
  • Pays de l'événement
    Philippines
  • Source de l'événement
    FDAP
  • URL de la source de l'événement
    https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/498910-fda-advisory-no-2018-114
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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