Events

Rappel de Device Recall Baxter Meridian

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Baxter Healthcare Corp..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    25079
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0605-03
  • Date de mise en oeuvre de l'événement
    2002-11-15
  • Date de publication de l'événement
    2003-03-05
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2003-09-19
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25117
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Dialyzer, High Permeability With Or Without Sealed Dialysate System - Product Code KDI
  • Cause
    Meridian hemodialysis instrument may reset when in shutdown mode causing the system to reset with potential for patient increased bioburden exposure.
  • Action
    Baxter issued a Safety Alert letter dated 11/15/02 to the direct accounts informing them of the potential for incomplete disinfection of the Meridian instrument during the Renalin/Formalin disinfection cycle due to electomagnetic interference (EMI). The accounts were informed that they will be receiving a radio frequency interference (RFI) filter kit and installation instructions to eliminate EMI by 2/28/03. The accounts were given instructions to follow to ensure that the Renalin/Formalin disinfection cycle has been completed prior to use of the machine.

Device

Device Recall Baxter Meridian
  • Modèle / numéro de série
    product codes 5M5576, 5M5576R, serial numbers 200000 through 202864
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide, Mexico, China, South Korea, Hong Kong
  • Description du dispositif
    Baxter Meridian Hemodialysis Instrument, product code 5M5576 and 5M5576R; Baxter Healthcare Corporation, McGaw Park, IL 60085 || The instrument is part of a high permeability hemodialysis system which consists of a controlled dialysate delivery system that incorporates an ultrafiltration controller to prevent excessive loss of water from the patient''s blood, an extracorporeal blood set, and a high permeability dialyzer. The standard features of the Meridian instrument incluide a high blood flow rate capacity (for shortened hemodialysis treatment time), automatic ultrafiltration control, standard and variable bicarbonate and sodium capabilities anbd automated chemical disinfection. The Meridian will operate in either the bicarbonate or acetate mode for concentrates.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

Baxter Healthcare Corp.
  • Adresse du fabricant
    Baxter Healthcare Corp., Rt 120 & Wilson Rd, Round Lake IL 60073
  • Source
    USFDA