Events

Alerte De Sécurité sur Tubing set, dialysis/haemodialysis (4008 HD Bloodlines)

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 AG & Co KGaA.

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
    2018-04-13
  • Date de publication de l'événement
    2018-04-13
  • 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_20180413b.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 medical care australia - tubing set, dialysis/haemodialysis (4008 hd bloodlines) therapeutic goods administration (tga), australia, has issued a medical device safety alert concerning 4008 hd bloodlines [av/fres 2008-4008 (f00007119) and av/fres 4008 (f00007120)], manufactured by fresenius medical care ag & co kgaa. the manufacturer has been made aware of incidents regarding quality, safety and performance of the 4008 hd bloodlines tubing. the currently supplied roller clamp may cause customers to experience difficulties in handling that might result in excessive force being used to close the clamp causing the roller part to detach. this may cause infusion of saline solution in the event of incorrect use of the roller clamp, if the second clamp present on the arterial line is also damaged or not closed. according to the manufacturer, a number of leakages were reported at several locations on the 4008 bloodline tubing systems. leakages on the bloodlines may cause blood loss into the environment and may lead to air intake into the system. while the air intake is normally detected by the dialysis machine’s air detector, a leakage of blood may not be detected. the affected users are advised to follow the instructions for use in each carton box of the hd bloodlines: ensure that all caps and connections are secure; inspect the extracorporeal circuit for leaks during priming phase and treatment, taking corrective measures (e.G. tightening luer-lock connection) or exchanging the bloodline as necessary; ensure that no excessive force is applied on the roller clamp on the reinfusion set in order to regulate the flow of fluid through the infusion pathway. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 13 april 2018.

Device

Tubing set, dialysis/haemodialysis (4008 HD Bloodlines)
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Fresenius Medical Care Australia - Tubing set, dialysis/haemodialysis (4008 HD Bloodlines)
  • Manufacturer
    Fresenius Medical Care AG & Co KGaA

Manufacturer

Fresenius Medical Care AG & Co KGaA