The Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom posted a field safety notice (FSN) concerning Bubble Trap VBT 160 and Custom Tubing Sets containing the Venous Bubble Trap VBT 160 manufactured by Maquet Cardiopulmonary AG. The following products are affected:
The manufacturer received complaints from several customers who reported that during use, the Venous Bubble Trap (VBT) draws air into the system. Internal investigation by the manufacturer confirmed the customer reports and it was determined that a manufacturing defect in the production of the bubble trap is responsible for the intrusion of air into the system during use.
As the main function of the VBT is to remove air from the system during use, the manufacturer considers this defect to present an unacceptable increased level of risk for the patient. If unaddressed, this could result in air entering the circulatory system of the patient and causing severe injury and the possibility of death.
The manufacturer has received no reports that the defect present in the VBT has resulted in a serious injury or death to any patient.
Users of the affected products were advised to take the actions mentioned in the FSN.
For details, please refer to MHRA website:
http://www.mhra.gov.uk/home/groups/fsn/documents/fieldsafetynotice/con445987.pdf
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 19 August 2014