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 Australian Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning Medtronic, Inc Duet External Drainage and Monitoring System (EDMS) [Multiple Lot Numbers] [HKMD number: 140325].
According to the TGA, the manufacturer received customer complaints alleging instances of the Duet catheter tubing disconnecting at the stopcock or Luer connector. If a tubing disconnection occurs, potential harm to patients may include infections, cerebrospinal fluid leakage, over drainage of cerebrospinal fluid, and abnormality of the ventricles. Uncontrolled over drainage of cerebral spinal fluid could lead to neurological injury or death if the disconnection is undetected. The types of patient harms that have been reported in the complaints include cerebrospinal fluid (CSF) leakage and infection. No serious neurological injuries or patient deaths have been reported.
For further information, please visit https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2024-RN-00055-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 24 Jan 2024