Events

Retiro De Equipo (Recall) de Device Recall Hospira MedNet Medication Management Suite

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Hospira Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    68658
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2027-2014
  • Fecha de inicio del evento
    2014-06-06
  • Fecha de publicación del evento
    2014-07-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-12-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128401
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Pump, infusion - Product Code FRN
  • Causa
    Hospira mednet 5.5, 5.8.1, and 5.8.2 contains software defect where the dosing units of "nanog/kg/min" and "milliunits/min" are not sent to a plum a+ device (version 13.40, 13.41, and 13.4.2) via auto programming when those dosing units are not properly established in the customized drug library. a dosing unit mismatch of "nanog/kg/min" or "milliunits/min" on an unmatched medication will produce a.
  • Acción
    Hospira sent an URGENT MEDICAL DEVICE CORRECTION letter dated June 6, 2014 was sent to all affected customers. The letter included instructions for customers to: notify all potential users in their organization of the recall, and to complete and return the attached reply form. The letter further notified customers that they will be contacted by a member of Hospira's Clinical Services Team to make arrangements to review the drug library and implement the appropriate mitigation. Hospira will further work with the direct account to ensure Auto Programming installations receive Pharmacy consulting to support the implementation of the mitigation and that a correction for this issue will be addressed in a future version of the software. Reports of adverse events or product complaints can be made by contacting Hospira Global Complaint Management at 800-441-4100 (Monday - Friday, 8:00 AM - 5:00 PM CST) or via e-mail at ProductComplaintsPP@hospira.com. Additional information or technical assistance can be obtained by contacting the Hospira Advanced Knowledge Center at 800-241-4002, option 4 (24 hours a day, 7 days a week).

Device

Device Recall Hospira MedNet Medication Management Suite
  • Modelo / Serial
    1) Software Version 5.5, List Number: 16037-04-13;  2) Software Version 5.8.1, List Number: 16037-04-31;  3) Software Version 5.8.2, List Number: 16037-04-33
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide in the states of FL, LA, PA, WA, WY and the country of Hong Kong
  • Descripción del producto
    The Hospira MedNet Medication Management Suite (MMS). || Product Usage: || The Hospira MedNet Medication Management Suite (MMS) is intended to facilitate networked communication between MMS compatible computer systems and Hospira infusion pumps. The MMS provides trained healthcare professionals with the capability to send, receive, report, and store information from interfaced external systems, and to configure and edit infusion programming parameters. The MMS is intended to provide a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data. All data entry and validation of infusion parameters is performed by a trained healthcare professional according to physicians orders.
  • Manufacturer
    Hospira Inc.

Manufacturer

Hospira Inc.
  • Dirección del fabricante
    Hospira Inc., 275 N Field Dr, Lake Forest IL 60045-2579
  • Empresa matriz del fabricante (2017)
    Pfizer
  • Source
    USFDA