Events

Alerte De Sécurité sur CADD Administration Sets with Flow Stop

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong 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
  • Date
    2016-05-10
  • Date de publication de l'événement
    2016-05-10
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160510a.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: smiths medical cadd administration sets with flow stop medical device manufacturer, smiths medical, has issued a medical device safety alert concerning its cadd administration sets with flow stop. the following products re-order numbers for devices with a device expiration date on or before march 2021 are affected: 21-7321-01, 21-7321-24, 21-7322-01, 21-7322-24, 21-7323-24, 21-7324-01, 21-7324-24, 21-7333-24, 21-7336-01, 21-7336-24, 21-7339-01, 21-7339-24, 21-7359-01, 21-7359-24, 21-7383-01, 21-7383-24, 21-7390-01, 21-7390-24, 21-7391-01, 21-7391-24, 21-7394-01, 21-7394-24, 21-7395-24]. the affected products have the potential to impact flow rate when used with a variety of cadd ambulatory infusion pumps. this may result in under delivery of medication. the manufacturer’s test data indicates that under infusion has the potential to contribute to an average of an additional 5.2% under delivery beyond the +/- 6% stated in the operator’s manual for the cadd pumps. the manufacturer’s risk analysis identified the following possible serious adverse health consequences with a very remote probability of occurrence: 1) inadequate symptom control (dependent on therapy being delivered). for example: increase in pain or increase in cardiac symptoms (heart rate, rhythm, blood pressure); 2) inadequate treatment (dependent on therapy being delivered). for example: subtherapeutic doses delivered of medication in which a specific volume needs to be infused such as antibiotics, chemotherapy, or nutritional therapy. the manufacturer concluded that there is a very remote probability that under delivery may occur resulting in patient harm, as all possible levels of patient harm were evaluated to be rare. the manufacturer is not requesting return of product. the manufacture advises users to continue to monitor for under delivery when utilising the cadd administration sets with flow stop. according to the manufacturer, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 10 may 2016.

Device

CADD Administration Sets with Flow Stop
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Smiths Medical CADD Administration Sets with Flow Stop Free
  • Manufacturer
    Smiths Medical

Manufacturer

Smiths Medical