Events

Alerte De Sécurité sur Solution for Dialysis in Renal Replacement Therapy

Selon National Institute of Drugs and Food Surveillance (INVIMA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Colombia qui a été fabriqué par Gambro Renal Products, Inc..

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
  • ID de l'événement
    R1607-274
  • Numéro de l'événement
    2010DM-0005701
  • Date
    2016-07-07
  • Pays de l'événement
    Colombia
  • Source de l'événement
    INVIMA
  • URL de la source de l'événement
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=133
  • Notes / Alertes
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notes supplémentaires dans les données
  • Cause
    The manufacturer has detected the presence of leaks near the upper part of the bags of the device, which may cause microbial contamination of the dialysate, leading to potentially adverse events occurring in patients.

Device

Solution for Dialysis in Renal Replacement Therapy
  • Modèle / numéro de série
    105351 - PRISMASATE BGK 2/0, lots 1000123133 and 1000128162 distributed between 10/27/2015 and 01/30/2016.
  • Description du dispositif
    Adjuvant solution of hydro-electrolyte balance and PH in patients under renal substitution contains. The PRISMASATE solutions are sterile, to be used in patients under continuous renal replacement in patients with acute renal failure, and in other cases, when fluid or solute removal is required, as in cases of acute poisoning due to medications or drugs that can be dislodged, PRISMASATE does not enter contact with the patient's bloodstream. FIRMASATE solutions are sterile dialysis solutions to be used in continuous renal replacement therapy procedures during the treatment of renal insufficiency and in other indications where the removal of liquids or solutes is required, as in poisoning, which are dialysable.
  • Manufacturer
    Gambro Renal Products, Inc.

Manufacturer

Gambro Renal Products, Inc.