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 Iradimed Corporation MRidium MRI Syringe Adapter Set, Reference number: 1057 [HKMD No.: 220319].
According to the MHRA, the manufacturer has identified a problem with certain Iradimed 1057 Syringe Adapter Sets that are used with the MRidium MRI infusion pump. The identified problem relates to a defective injection moulded part that can limit the effectiveness of the syringe venting function which then can result in an occlusion with an associated Inlet Occlusion alarm. No patient injuries have been reported. Delays in therapy may occur as a result of an occlusion caused by improper venting of the 1057 Syringe Adapter Set, leading to a need for intervention in patient care and replacement of the occluded 1057 syringe set.
For further information, please visit https://mhra-gov.filecamp.com/s/d/68rMOM0LUv4nqs4i
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 23 Mar 2023