Events

Rappel de Device Recall Haemonetics cardioPAT Cardiovascular Perioperative Autotransfusion System

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 Haemonetics Corporation.

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
    59379
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2956-2011
  • Date de mise en oeuvre de l'événement
    2011-07-27
  • Date de publication de l'événement
    2011-08-05
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-06-09
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102445
  • 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
    Apparatus, autotransfusion - Product Code CAC
  • Cause
    Updated operations manual for the deployment of the spill collection system and cleaning.
  • Action
    Haemonetics sent a "FIELD NOTIFICATION: UPDATE OF CardioPAT OPERATIONS MANUAL FOR DEPLOYMENT OF SPILL COLLECTION BAG AND CLEANING" letter dated July 27, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter requests that customers complete an enclosed Customer Confirmation sheet indicating that the affected devices are in their possession and to return the sheet via fax to Haemonetics at 781-987-9252. Additionally, instructions for deployment of the spill collection drainage system, revised Operations Manual and Quick Reference Guide Addendum are enclosed with the letter. Contact Haemonetics at 1-800-537-2802 for questions regarding this notice..

Device

Device Recall Haemonetics cardioPAT Cardiovascular Perioperative Autotransfusion System
  • Modèle / numéro de série
    All serial numbers
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution--USA (nationwide) and the countries of Canada, France, Germany, Great Britain, Italy, Japan, Spain, and The Netherlands.
  • Description du dispositif
    Haemonetics cardioPAT -Cardiovascular Perioperative Autotransfusion System || Model 2050 US || Models Out-Side the US: || 02050-UK, 02050-ES, 02050-IT, 02050-NL, 02050-GE, 02050-FR, 02050-JA || The Haemonetics¿ Cardiovascular Perioperative Autotransfusion System || for Use (cardioPAT) is indicated for use to salvage red blood cells from blood lost intraoperatively and postoperatively during cardiovascular surgical || procedures, where the expected rate of processing of salvaged blood and fluid || aspirated from the surgical site is less than or equal to two liters per hour.
  • Manufacturer
    Haemonetics Corporation

Manufacturer

Haemonetics Corporation
  • Adresse du fabricant
    Haemonetics Corporation, 400 Wood Rd, Braintree MA 02184-2412
  • Société-mère du fabricant (2017)
    Haemonetics Corporation
  • Source
    USFDA