Events

Alerte De Sécurité sur LUNG HEART MACHINE JOSTRA HL 20

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par MAQUET CARDIOPULMONARY AG.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    967
  • Date
    2009-07-15
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    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.
  • Cause
    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.
  • Action
    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
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    ANVSANVISA