Events

Retiro De Equipo (Recall) de PAINSMART IOD (AMBULATORY INFUSION PUMP)

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por ZEVEX 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
    75256
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2011-03-20
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    There is the potential for a possible delay in therapy that may result during the use of software version 6r9 6r9a 6r9b 6r9c 6r9d and 6r9e. pumps programmed with previously mentioned software revisions may display a false error code 45 (motor condition loss of sync). this software anomaly renders the device in-operable until a recovery process is performed. recovery from error code 45 requires a power cycle of the pump during which the date time and all customized therapeutic parameters are lost. the recovery process requires all such parameters to be re-inputted by the clinician prior to beginning or resuming therapy.

Device

PAINSMART IOD (AMBULATORY INFUSION PUMP)
  • Modelo / Serial
    Model Catalog: 360-1300 (Lot serial: Contact manufacturer.); Model Catalog: 360-1300 (Lot serial: >10 serial numbers.); Model Catalog: 360-1300P (Lot serial: Contact manufacturer.); Model Catalog: 360-1200 (Lot serial: >10 serial numbers.); Model Catalog: 360-1200 (Lot serial: Contact manufacturer.); Model Catalog: 360-1300P (Lot serial: >10 serial numbers.); Model Catalog: 360-1400 (Lot serial: >10 serial numbers.); Model Catalog: 360-1100 (Lot serial: >10 serial numbers.); Model Catalog: 360-1400 (Lot serial: Contact manufacturer.); Model Catalog: 360-1100 (Lot serial: Contact manufacturer.)
  • Descripción del producto
    PainSmart IOD (Ambulatory Infusion Pump)
  • Manufacturer
    ZEVEX INC.

Manufacturer

ZEVEX INC.
  • Dirección del fabricante
    SALT LAKE CITY
  • Empresa matriz del fabricante (2017)
    Moog Inc
  • Source
    HC