Events

Retiro De Equipo (Recall) de Transonic Hemodialysis Monitor

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Transonic Systems 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
    18294
  • Fecha de inicio del evento
    2015-03-30
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: TekMed NZ Pty Ltd, Hilary Square, Orewa, Orewa 0946
  • Causa
    This recall is being initiated because of customer complaints indicating the inability to obtain measurements due to the device sometimes seeing no flow or irrelevant flow condition when used with patients during dialysis procedures. no reports of injuries have been reported nor are expected due to the nature of this issue., the problem is readily identified to the user by a zero or a very low flow value displayed on hd03 and/or no measurements produced in other modes (recirculation; access flow; or cardiac output).
  • Acción
    Product to be modified

Device

Transonic Hemodialysis Monitor
  • Modelo / Serial
    Model: Catalogue Number: HD03, Affected: Lot Numbers: A81225, A91394 & B21812
  • Manufacturer
    Transonic Systems Inc

Manufacturer

Transonic Systems Inc