Events

Alerta De Seguridad para Gemstar Infusion 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
    2013-03-25
  • Fecha de publicación del evento
    2013-03-25
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130325.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
    Medical device safety alert: hospira gemstar infusion pump medical device manufacturer, hospira inc has initiated a field safety corrective action concerning gemstar infusion pump which four potential risks were identified to be related to the device. the affected list numbers are 13000, 13150 and 13087. according to hospira, the affected pumps may have the following problems: (1) gemstar lithium battery - low voltage 11/004 error will be displayed and the device will not be able to be used (2) gemstar battery leakage aa battery leakage may cause the device to shut off without warning (3) gemstar pressure sensor calibration drift the proximal and distal pressure sensor calibration can drift resulting in the pump failing the proximal or distal occlusion operational test. (4) gemstar backward motor movement when the pump is stopped or the flow rate is less than 2.0 ml/hour, the motor assembly may rotate backwards capturing additional medication that will be delivered. x091/001 error will be displayed. hospira warns the users that a delay in therapy may be resulted. the affected users are advised to: replace lithium batteries that are older than three years; inspect the internal aa batteries and battery compartment for signs of leakage, corrosion or other damage prior to each use; add the proximal and distal occlusion test to the yearly gemstar maintenance schedule and remove the device from clinical use if it fails either of the tests; remove the device from clinical use if it displays an x09/001 error. the local supplier confirmed that the affected products have been distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 25 march 2013.

Device

Gemstar Infusion Pump
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Hospira Gemstar Infusion Pump
  • Manufacturer
    Hospira Inc

Manufacturer

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