Events

Rappel de Baxter Meridian Hemodialysis Instrument

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 Renal Div.

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
    33632
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0275-06
  • Date de publication de l'événement
    2005-12-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2006-11-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42188
  • 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
    Inadequate instructions for routing single tubing lines through the double-tubing clips on the front of the instrument to eliminate the risk of kinks in the tubing, which have been associated with a death and a serious injury.
  • Action
    Urgent Device Recall letters dated 9/28/05 were sent to all Meridian accounts on the same date, to the attention of the Hemodialysis Administrator, with copies sent to the Chief Technician and Hemodialysis Charge Nurse. The letters informed the accounts of teh death and serious injury related to kinks in blood tubing sets used on the Meridian machine, and that there is an increased risk of kinks to occur at the double-tubing clips mounted on the front of the Meridian. The risk increases when a single tubing line is routed through both retainers on either clip. The letter included diagrams showing the correct and incorrect use of the clips, provided labels, with placement instructions, to be placed on the Meridian machine indicating the correct and incorrect placement of tubing, and informed the users that replacement clips with single channels will be installed when they become available. Follow-up letters were sent to the accounts on 12/22/05, providing training material to ensure that the accounts are aware of proper blood tubing set-up and understand the conditions which may result in hemolysis, and on 12/23/05, informing them that the replacement clips were available for installation, giving the accounts the option of having Baxter install them or sending the clips to the account for self-installation.

Device

Baxter Meridian Hemodialysis Instrument
  • Modèle / numéro de série
    all serial numbers, beginning with 20000
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide and internationally to Mexico and Asia.
  • Description du dispositif
    Baxter Meridian Hemodialysis Instrument, product codes 5M5576 and 5M5576R; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085 U.S.A.
  • Manufacturer
    Baxter Healthcare Renal Div

Manufacturer

Baxter Healthcare Renal Div
  • Adresse du fabricant
    Baxter Healthcare Renal Div, 1620 Waukegan Rd Bldg R, Mc Gaw Park IL 60085-6730
  • Source
    USFDA