Important Safety Alerts

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