Events

Alerta De Seguridad para GemStar™ Bolus Cord used with Gemstar™ Pump

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Hospira Inc.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2012-03-22
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120322d.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Field safety notice: hospira gemstar™ bolus cord used with gemstar™ pump it has come to our attention that the health canada was aware of problems associated with the gemstar™ bolus cord, used with the gemstar™ pump manufactured by hospira inc. post-market incident reports indicate that defects with these cords can lead to failure to deliver, intermittent operation, and unrequested bolus delivery. the gemstar™ pump has software controls that set a maximum allowable dosage and minimum lockout time. an audible chirp signals for every requested delivery and provides notification to the patient and attendant staff. these safety provisions help to mitigate the potential risk to the patient. the health canada has not received any reports of patient injury. the manufacturer's preliminary investigation suggests that the cord may be damaged by the force applied to remove the cord from the base of the gemstar™ unit. this may lead to cracking and open circuits or short circuits. if you are in possession of the product, please contact your supplier for necessary actions.

Device

GemStar™ Bolus Cord used with Gemstar™ Pump
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Hospira GemStar™ Bolus Cord used with Gemstar™ Pump
  • Manufacturer
    Hospira Inc

Manufacturer

Hospira Inc
  • Empresa matriz del fabricante (2017)
    Pfizer
  • Source
    DH