Events

Alerte De Sécurité sur Naturalyte Liquid Acid Concentrate and Naturalyte GranuFlo (powder) Acid Concentrate

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Fresenius Medical Care North America.

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
    2012-06-28
  • Date de publication de l'événement
    2012-06-28
  • 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_20120628a.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: fresenius naturalyte liquid acid concentrate and naturalyte granuflo (powder) acid concentrate the united states food and drug administrations (fda) has issued a class i recall concerning naturalyte liquid acid concentrate and naturalyte granuflo (powder) acid concentrate distributed by fresenius medical care north america. please refer to the fda website for the affected serial numbers. the manufacturer is cautioning clinicians to be aware of the concentration of acetate or sodium diacetate (acetic acid plus acetate) contained in the products as mentioned above. inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis. this may contribute to metabolic alkalosis, which is a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which, if not appropriately treated, may culminate in cardiopulmonary arrest. this product may cause serious adverse health consequences, including death. the fda recommended that health care providers should review the dialysate acid concentrate labeling for the specific concentrate that they prescribe to determine the components that can contribute to the patient's overall bicarbonate levels. according to the local supplier, the affected products were not distributed in hong kong. for details, please refer to fda websites: http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ ucm305630.Htm and http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm309990.Htm if you are in possession of the product, please contact your supplier for necessary actions. posted on 28 june 2012.

Device

Naturalyte Liquid Acid Concentrate and Naturalyte GranuFlo (powder) Acid Concentrate
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Fresenius Naturalyte Liquid Acid Concentrate and Naturalyte GranuFlo (powder) Acid Concentrate
  • Manufacturer
    Fresenius Medical Care North America

Manufacturer

Fresenius Medical Care North America