Events

Safety Alert for maquet heart-lung machine hl 30

According to Department of Health, this safety alert involved a device in Hong Kong 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
  • Date
    2013-02-08
  • Event Date Posted
    2013-02-08
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130208.html
  • Notes / Alerts
    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.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: maquet heart-lung machine hl 30 medical device manufacturer, maquet cardiopulmonary ag issued a medical device safety alert concerning heart-lung machine hl 30. the manufacturer has identified two potential issues with the hl30 devices which will be addressed in a software upgrade: first, in rare instances, as a result of an accidental impact or 'bump' to the pump head cover, the unit may stop. this stoppage is intended to occur by design, whenever the pump head cover is opened during operation. however, if the impact is rapid, the unit may stop without an informational message explaining the reason behind. second, there is a software anomaly in the cardioplegia module whereby, in a limited number of cases, the unit slave pump did not engage after cardioplegia pause. no patient injury has been reported in either issue. 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 8 february 2013.

Device

maquet heart-lung machine hl 30
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: MAQUET Heart-lung Machine HL 30
  • Manufacturer
    MAQUET Cardiopulmonary AG

Manufacturer

MAQUET Cardiopulmonary AG