Events

Retiro De Equipo (Recall) de AMIA AUTOMATED PD SET WITH CASSETTE (DISPOSABLE SET)

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por BAXTER CORPORATION.

¿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
    56153
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2017-09-06
  • 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
    Baxter corporation is issuing a product recall for certain lots of the amia automated peritoneal dialysis set with cassette in response to increased customer complaints received for missing red line patient slow flow solution slow flow and inadequate drain alerts. increased frequency of these alerts could lead to insufficient draining of waste solution which can be a contributing factor in fluid overload.

Device

AMIA AUTOMATED PD SET WITH CASSETTE (DISPOSABLE SET)
  • Modelo / Serial
    Model Catalog: 5C5479 (Lot serial: H16J05035); Model Catalog: 5C5479 (Lot serial: H16I21058); Model Catalog: 5C5479 (Lot serial: H16I14103); Model Catalog: 5C5479 (Lot serial: H16I02017); Model Catalog: 5C5479 (Lot serial: H16H26034); Model Catalog: 5C5479 (Lot serial: H16H09063); Model Catalog: 5C5479 (Lot serial: H16H04114); Model Catalog: 5C5479 (Lot serial: H16J07015); Model Catalog: 5C5479 (Lot serial: H16H30010)
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Descripción del producto
    AMIA AUTOMATED PERITONEAL DIALYSIS SET WITH CASSETTE
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION