Events

Rappel de Device Recall LifeCare PCA infusion System with Hospira MedNet

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
    64230
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2873-2016
  • Date de mise en oeuvre de l'événement
    2013-03-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-11-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115632
  • 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, pca - Product Code MEA
  • Cause
    Screw rotation error occurring when the pump detects a mismatch between the number of steps given to the motor driving delivery and the number of steps the motor actually took. when this malfunction occurs, the pump will alarm and infusion stops.
  • Action
    Hospira will contract with Stericycle, Inc. in Indianapolis, IN to send letter and a reply form to Hospira, Inc. Receipt of the letters will be confirmed by UPS tracking. Customers will be requested to return a reply form to Stericycle indicating the number of pumps on hand and that they have received the letter and notified their users. In addition, letters will be sent by email to ECRI, NRAC, Noblis and ISMP for notification of their members and posting on their websites. The letter will also be posted to the Hospira website. Letters will be sent to Hospira customers of record who purchased the devices directly from Hospira. Customers will be directed to notify their consignees if they further distributed the product and confirm they have done so. Telephone attempts will be made to contact customers that do not respond in order to confirm receipt of the letter. Final effectiveness will be done as the devices are upgraded with new plastic motors.

Device

Device Recall LifeCare PCA infusion System with Hospira MedNet
  • Modèle / numéro de série
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    United States (Nationwide) Distribution including Puerto Rico and American Virgin Islands.
  • Description du dispositif
    LifeCare PCA Infusion System with Hospira MedNet Software, PCA Serial List Number 20709 || Allows for clinician administration or self-administration of analgesic medications.
  • 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