Events

Retiro De Equipo (Recall) de CWP 60 SYSTEM (CENTRAL WATER TREATMENT SYSTEM FOR HEMODIALYSIS)

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
    71414
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-11-21
  • 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 device correction for specific models of the central water plant (cwp) reverse osmosis units in order to correct the insufficient crimping of the cables within the main pump. the issue was identified as a result of customer complaints received for the presence of smoke in the water treatment room due to the overheating of the pump in the cwp. as part of baxter's investigation based on pictures provided from the event the most likely cause of the thermal event was due to the crimp of the cables for the main pump being insufficient. to minimize any potential side effects of thermal events please ensure all panels of the cwp are in place.

Device

CWP 60 SYSTEM (CENTRAL WATER TREATMENT SYSTEM FOR HEMODIALYSIS)
  • Modelo / Serial
    Model Catalog: WRO63 (Lot serial: > 100 numbers contact mfg); Model Catalog: WRO 106H (Lot serial: > 100 numbers contact mfg); Model Catalog: WRO 104S (Lot serial: > 100 numbers contact mfg); Model Catalog: WRO112 (Lot serial: > 100 numbers contact mfg); Model Catalog: WRO113 (Lot serial: > 100 numbers contact mfg); Model Catalog: WRO111 (Lot serial: > 100 numbers contact mfg); Model Catalog: WRO102H (Lot serial: > 100 numbers contact mfg); Model Catalog: WRO103S (Lot serial: > 100 numbers contact mfg); Model Catalog: WRO101H (Lot serial: > 100 numbers contact mfg); Model Catalog: WRO104H (Lot serial: > 100 numbers contact mfg); Model Catalog: WRO103H (Lot serial: > 100 numbers contact mfg); Model Catalog: WRO 106S (Lot serial: > 100 numbers contact mfg); Model Catalog: WRO102S (Lot serial: > 100 numbers contact mfg); Model Catalog: WRO101S (Lot serial: > 100 numbers contact mfg); Model Catalog: WRO103H(P) (Lot serial: > 100 numbers contact mfg); Model Catalog: WRO102H(P) (Lot serial: > 100 numbers contact m
  • Descripción del producto
    Central Water Plant Reverse Osmosis Unit (CWP 60);Central Water Plant Reverse Osmosis Unit (CWP 100)
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION