Events

Safety Alert for LUNG HEART MACHINE JOSTRA HL 20

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by MAQUET CARDIOPULMONARY AG.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    967
  • Date
    2009-07-15
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the 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.
  • Reason
    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
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    ANVSANVISA