Events

Retiro De Equipo (Recall) de PCS2 PLASMA COLLECTION SYSTEM - DISPOSAL COLLECTION KITS

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por HAEMONETICS 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
    138341
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2010-06-10
  • 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 a defect in a very small number of plasma bowls in which a portion of the wall of the bowl may be too thin. there is a potential that a defective bowl may leak or fail within the centrifuge chamber during a plasma collection procedure. if a leak or failure were to occur the pcs2 system is designed to detect the problem and safely terminate the collection procedure. however it is possible that blood could escape from the device and spray into the surrounding environment and onto surrounding objects or people.

Device

PCS2 PLASMA COLLECTION SYSTEM - DISPOSAL COLLECTION KITS
  • Modelo / Serial
    Model Catalog: 0625B-00 (Lot serial: >10 numbers contact mfg)
  • Descripción del producto
    Plasma Bowl 0625B-00
  • Manufacturer
    HAEMONETICS CORPORATION

Manufacturer

HAEMONETICS CORPORATION