Events

Retiro De Equipo (Recall) de Sigma Spectrum VOLUMETRIC INFUSION PUMP

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 Sigma International General Medical Apparatus, Llc.

¿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
    56833
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0146-2011
  • Fecha de inicio del evento
    2010-09-15
  • Fecha de publicación del evento
    2010-11-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-06-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94606
  • 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
    Infusion pump - Product Code FRN
  • Causa
    The infusion pumps have the potential to fail causing inaccurate flow conditions during use. these conditions range from back flow to free flow, which could result in over-infusion.
  • Acción
    Urgent: Medical Device Recall Notification letters and forms (dated 9/14/10) were sent to the consignees via Certified Mail on/about 9/15/10. The letters inform the consignees of the recall of the pumps since these units may fail suddenly causing inaccurate flow conditions during use, ranging from back flow to over-infusion, including free flow. Consignees are instructed to check their inventory to verify whether their serial numbers fall within the range of pumps being recalled. Due to possible bearing failure, SIGMA is taking the precautionary measure of servicing or replacing all affected Spectrum Infusion Pumps and is requiring the return of the recalled devices to its facility. SIGMA has provided the following instructions for users: (1) Do not use the affected Spectrum Infusion Pumps on patient populations where inaccurate flow, ranging from back flow to over-infusion, including free flow, could result in serious adverse health consequences or death. (2) Do not use on neonatal patients. -- If the user facility has no acceptable alternative methods for delivering therapy, the user should weigh the risks and benefits for the continued use of the affected pumps. If you must use these pumps, SIGMA recommends the following actions which may mitigate the risk. (1) for pediatric and adult patients, an add-on Buretrol may limit the amount of an over-infusion if the failure occurs. Always follow the Buretrol manufacturer's instructions. (2) consider using air-eliminating filters. Under free flow conditions pumps cannot stop fluid flow. If air is in the line with fluid, the air will also infuse. (3) Frequently observe that the drip rate (mL/hr) compares to the programmed pump flow rate. Also, make an observation of the container volume to make sure it is correct. If a discrepancy is observed, immediately remove the pump from service and treat the patient as appropriate. There are additional instructions to Asset Management Customers: SIGMA requests that each A

Device

Sigma Spectrum VOLUMETRIC INFUSION PUMP
  • Modelo / Serial
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library, Part Number 35700 -- || Common/Classification Name: Infusion Pump --Class 2 medical device -- SIGMA LLC, Medina, NY 14103 -- Shipping box label: Infusion Pump SIGMA Model 35700 (with accessories), SIGMA International, Inc. Medina, NY 14103 ** Serial Number: XXXXXX. || To be used in a healthcare facility in an IV pole mounted configuration or carried by the user in an ambulatory manner.
  • Manufacturer
    Sigma International General Medical Apparatus, Llc

Manufacturer

Sigma International General Medical Apparatus, Llc
  • Dirección del fabricante
    Sigma International General Medical Apparatus, Llc, 711 Park Avenue, Medina NY 14103-1036
  • Empresa matriz del fabricante (2017)
    Baxter International
  • Source
    USFDA