Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has posted a medical device safety alert concerning Baxter Healthcare Corporation MiniCap Extended Life PD Transfer Set with Twist Clamp and MiniCap Extended Life PD Transfer Set with Twist Clamp (Extra Short) [HKMD No.: 140102].
According to the MHRA, the manufacturer is issuing a Safety Alert for the MiniCap Extended Life PD Transfer Sets due to an increase in complaints related to the separation of the female connector from the main body of the transfer set. These separations may occur while connecting or disconnecting from PD therapy products. However, as the tubing remains attached to the dark blue female connector during a separation, the sterile fluid path is maintained, and there is no risk of microbial contamination that will result from the separation itself.
Separation of the female connector from the main body of the transfer set would not directly lead to a breach in sterility of the fluid path. However, Baxter has received reports of patients subsequently cutting the patient line and/or not following aseptic technique when trying to address the separation. This may increase the risk of peritonitis.
For further information, please visit: https://mhra-gov.filecamp.com/s/d/2ahbjSLgNx8HEV70
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 30 Oct 2024