Events

Rappel de 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
    36361
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0169-2007
  • Date de mise en oeuvre de l'événement
    2006-09-06
  • Date de publication de l'événement
    2006-11-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2006-12-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48483
  • 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
    Hemodialysis - Product Code KDI
  • Cause
    The meridian pump is less likely to detect small pressure changes, which may indicate the presence of a post-pump tubing kink, when using pre-pump arterial pressure monitoring.
  • Action
    Urgent Device Correction letters dated 9/6/06 were sent to the Meridian accounts on the same date via UPS second day, to the attention of the Hemodialysis Administrator. The letters informed the accounts of the potential risk associated with a post-pump bloodline kink when using pre-pump arterial pressure monitoring. The accounts were provided with a revised Meridian Operator''s Manual which includes the following warnings: 'The lower venous limit should be set as close to the currently displayed venous pressure as conditions allow.' and 'Reliance on the pressure alarms should not substitute for clinical monitoring of the patient for adverse events.' Any technical questions were directed to Baxter Global Technical Services at 1-800-553-6898, prompt 3, option 2, choice 2. General questions were directed to The Center for One Baxter at 1-800-422-9837.

Device

Meridian Hemodialysis Instrument
  • Modèle / numéro de série
    all serial numbers
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide and Hong Kong, Korea and China
  • Description du dispositif
    Meridian Hemodialysis Instrument, product code 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