The Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom posted a field safety notice concerning Single Needle Bloodlines for AK Machines, manufactured by Gambro. The affected product codes (with batch numbers) are 114524 (Batch Number: From 1317 to 1350), 114561 (Batch Number: From 1316 to 1401) and 114527 (Batch Number: From 1316 to 1321) respectively.
According to the manufacturer, there is a possible defect on the concerned products, involving a potential bonding of the venous male luer with the drain bag connector and/or of the arterial male luer with the spike connector. When the defect occurs, the cone of the luer may be damaged if the operator forces the disconnection of the bonded luer. Performing a treatment with a damaged luer connection could result in an intake of air into the bloodline which could potentially reach the patient and would not pass through the "air in blood" protective system of the dialysis machine.
The manufacturer advises users not to use the affected products, but, instead, use product from different lots or similar product as available. The affected product will be collected and replaced by the manufacturer.
For details, please refer to the following link:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON391268
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 18 March 2014