Events

Rappel de Device Recall Outlook ES Safety Infusion 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 B Braun Medical, Inc..

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
    64152
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-2188-2013
  • Date de mise en oeuvre de l'événement
    2012-11-14
  • Date de publication de l'événement
    2013-09-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-03-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115432
  • 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
    Pump, infusion - Product Code FRN
  • Cause
    This notice is being provided in follow up to the field correction initiated by b. braun medical inc. on august 26, 2011 due to an issue in which the outlook es safety infusion system may halt infusion but the "run" light emitting diodes (leds) on the front display continue to advance as if the pump were infusing. the pump emits a backup alarm, but there are no visual indicators that the infusion.
  • Action
    The firm, B Braun Medical Inc, sent an "Urgent Expanded Medical Device Field Correction" letter dated November 14, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed that pumps that have been upgraded (software version 151599 or higher), no additional action is required on their part at this time. For the pumps that have not yet been upgraded, within three weeks of the letter, customers should confirm the serial numbers using the enclosed response form or contact B. Braun Medical, Inc. Infusion Systems Customers Support at 1-800-627-7867 (800-627-PUMP) to schedule their upgrade. For questions regarding this recall call 972-245-2243.

Device

Device Recall Outlook ES Safety Infusion System
  • Modèle / numéro de série
    Model number: 621-300ES and 621-400ES. Multiple serial numbers affected.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution: USA including states of: AR, CA, FL, IL, LA, NC, NJ, NY, MD, ME, MN, SC, TN, TX, VA, WI, and WV.
  • Description du dispositif
    Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid container is lower than the pump), and provides clinically accepted volumetric accuracy for all standard IV fluids, including blood, lipid, and Total Parenteral Nutrition (TPN). Model number: 621-300ES and 621-400ES. To deliver a broad range of drugs with use with the B. Braun Medical Inc. Horizon Pump IV Sets.
  • Manufacturer
    B Braun Medical, Inc.

Manufacturer

B Braun Medical, Inc.
  • Adresse du fabricant
    B Braun Medical, Inc., 1601 Wallace Dr Ste 150, Carrollton TX 75006-6690
  • Société-mère du fabricant (2017)
    Ludwig G. Braun Gmbh U. Co. Kg
  • Source
    USFDA