Events

Retiro De Equipo (Recall) de Device Recall LifeCare PCA 3

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
    64230
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2874-2016
  • Fecha de inicio del evento
    2013-03-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-11-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148422
  • 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, pca - Product Code MEA
  • Causa
    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.
  • Acción
    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 3
  • Modelo / Serial
    Serial Number 12921204  12922976  12924008  12925861  12925924  12925998  12928528  12928807  12929016  12929126  12920432  12920820  12920856  12920915  12921404  12921413  12922304  12922976  12925861  12925998  12927215  12929016  12931044  12931141  12931155  12931192  12931244  12931342  12931361  12931413  12931610  12931639  12931649  12931911  12921480  12921487  12923723  12924326  12924350  12924546  12925259  12925447  12926315  12927938  12928075  12928614  12930418  12930709  12930890  12931441  12931760  12931911  12932487  12932717  12920754  12920791  12920897  12921063  12921613  12922062  12923441  12924161  12926859  12927756  12928775  12929346  12929438  12931942  12920112
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    United States (Nationwide) Distribution including Puerto Rico and American Virgin Islands.
  • Descripción del producto
    LifeCare PCA 3, PCA Serial List Number 12384 || Allows for clinician administration or self-administration of analgesic medications.
  • 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