Events

Alerta De Seguridad para LUNG HEART MACHINE JOSTRA HL 20

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por MAQUET CARDIOPULMONARY AG.

¿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
  • ID del evento
    967
  • Fecha
    2009-07-15
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notas adicionales en la data
    The malfunction described is caused by a problem in the welding process. This was identified due to a batch of printed circuit boards (PCBs), which did not meet Maquet's quality standards. The affected boards are those of Interconnect. The affected batch has number 70218. The affected plates were assembled in the HL20 Twin Pumps TPM20-330 (Art No. 703323), whose numbers of affected series are: 93201074; 93201081; 93201082; 93201083; 93201084; 93201085; 93201086; 93201087; 93201088; 93201097; 93201102; 93201103; 93201105; 93201107. Source: Maquet Cardiopulmonary do Brasil Indústria e Comércio S / A.
  • Causa
    In rare cases, the hl20 tpm20-330 double pump may malfunction when in use in slave cardioplegia mode. the malfunction is that the actual rpm of the pump when in slave cardioplegia mode, in rare cases differs from the selected value. if this malfunction occurs, the safety system will be activated. the safety system will stop the cardiopulgence pump in question and an error message will be displayed on the device's display.
  • Acción
    Recommendations for healthcare professionals: The Interconnection plates of all affected Double Pump Modules should be replaced as soon as possible. Contact your local MAQUET representative to replace the plates of your affected HL20 Double Pumps TPM20-330 (Art No. 703323) with a new one as soon as possible. Caution until corrective action is taken: In order to prevent any unnecessary risk to the patient, the company advises to disconnect, for example, the slave mode in the pump between the administrations of cardioplegia. Additionally, keep the cardioplegia delivery line clamped all the time between delivering cardioplegia to the patient's side in the connecting line.

Device

LUNG HEART MACHINE JOSTRA HL 20

Manufacturer

MAQUET CARDIOPULMONARY AG
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    ANVSANVISA