Events

Retiro De Equipo (Recall) de Device Recall Premixed Dialysate for Hemodialysis

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 NxStage Medical, 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
    79276
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1132-2018
  • Fecha de inicio del evento
    2017-11-10
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161806
  • 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.
  • Notas adicionales en la data
    Dialysate concentrate for hemodialysis (liquid or powder) - Product Code KPO
  • Causa
    Using different fluid formulations of nxstage pureflow b solution at the same time during treatment may cause patient health risk. the nxstage pureflow b solution is for use with systems that use one premixed dialysate during hemodialysis. the original labeling did not warn against mixing dialysate formulations and did not instruct staff to verify that the fluid is flowing during use.
  • Acción
    Customers are advised to : 1. Always make sure when using PureFlow B Solution that fluid is flowing freely from all bags. 2. Recognize that any practice of hanging more than one fluid type at the same time is not an intended use of the NxStage System One" (as it does not monitor fluid composition) and is not a labeled indication of PureFlow B solutions. 3. Please make sure that all users of PureFlow B Solution in your organization and other concerned persons are informed regarding this Field Safety Notice. 4. Complete the enclosed customer reply form and return it to NxStage. Returning the customer reply form promptly will confirm your receipt of this notification and prevent you from receiving repeat notices.

Device

Device Recall Premixed Dialysate for Hemodialysis
  • Modelo / Serial
    RFP-400 - M535RFP4000 RFP-400-BB - 00842289101258 RFP-401 M - 535RPF4010 RFP-401-BB - 00842289101265 RFP-402 - M535RFP4020 RFP-403 - M535RFP4030 RFP-404- M535RFP4040 RFP-405 - M535RFP4050 RFP-406 - M535RFP4060 RFP-453 - M535RFP4530 RFP-454 - M535RFP4540 RFP-455 - M535RFP4550 RFP-456 - M535RFP4560
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US nationwide distribution
  • Descripción del producto
    NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One
  • Manufacturer
    NxStage Medical, Inc.

Manufacturer

NxStage Medical, Inc.
  • Dirección del fabricante
    NxStage Medical, Inc., 350 Merrimack Street, Lawrence MA 01843-1748
  • Empresa matriz del fabricante (2017)
    Nxstage Medical Inc
  • Source
    USFDA