Events

Alerte De Sécurité sur Medfusion® Syringe Pump Models, Series 3500 and 4000

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
    2018-101
  • 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/497503-fda-advisory-no-2018-101
  • 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. 2018-101 voluntary recall of medfusion® syringe pump models, series 3500 and 4000 the food and drug administration (fda) informs the public and all concerned healthcare professionals that smiths medical has voluntarily recalled certain medfusion® syringe pump models, series 3500 and 4000, which were manufactured or serviced between february 2015 and november 2017, with the following product codes: model 3500 product codes model 4000 product codes 3500-0600-003500-0600-013500-0600-503500-0600-513500-0600-823500-3063500-4153500-500 4000-0101-504000-0101-514000-0105-504000-0105-514000-0106-004000-0106-01 smiths medical informed the fda that certain medfusion® syringe pump model series 3500 and 4000, which were manufactured or serviced between february 2015 and november 2017, may not be recognizing or may be misidentifying loaded medication syringes. the inability of a pump to recognize a syringe (i.E. the size of the syringe is unknown to the pump) result in an inability to complete pump programming. misidentification of a syringe may also occur, in which the pump misinterprets the syringe size. risk to health:             the inability of the pump to recognize a syringe can potentially lead to a delay in the           initiation of an infusion, due to clinicians being unable to complete programming.          interruption of therapy may also potentially occur if loss of recognition occurs during an active infusion (note: the pump will alarm in this scenario).             misidentification of syringe size may potentially result in over-delivery or under-      delivery if the clinician does not notice the pump’s misidentification of the syringe prior     to starting an infusion. distributors, retailers, hospitals and all healthcare professionals / users are advised to discontinue further distribution, sale and use of the said affected medical device product. 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. 2018-101.Pdf.

Device

Medfusion® Syringe Pump Models, Series 3500 and 4000

Manufacturer

Smiths Medical