Events

Rappel de Device Recall Symbiq Two Channel Infuser

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 Hospira 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
    63994
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0306-2017
  • Date de mise en oeuvre de l'événement
    2013-02-04
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-12-15
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115186
  • 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.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Notes supplémentaires dans les données
    Pump, infusion - Product Code FRN
  • Cause
    Symbiq infusers have the potential to experience a white screen during titration of a keep vein open (kvo) delivery. this can allow the clinician to select the "next" button prior to completion of the programming. if this error occurs, a delay in therapy could occur and potentially result in significant injury.
  • Action
    Hospira sent an Urgent Device Field Correction notice dated February 4, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to follow the steps provided in the letter while Hospira is developing a software change. Customers were asked to complete the attached reply form and return it via fax to the number on the form. Customers with questions were instructed to contact Stericycle at 1-888-201-9332. For questions regarding this recall call 224-212-4892.

Device

Device Recall Symbiq Two Channel Infuser
  • Modèle / numéro de série
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and Canada
  • Description du dispositif
    Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids. List number 16027. Note that Hospira retired this pump June 30, 2015. || The Hospira Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood, and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration.
  • Manufacturer
    Hospira Inc.

Manufacturer

Hospira Inc.
  • Adresse du fabricant
    Hospira Inc., 275 N Field Dr, Lake Forest IL 60045-2579
  • Société-mère du fabricant (2017)
    Pfizer
  • Source
    USFDA