Medical device manufacturer, Baxter Healthcare, has issued a medical device safety alert concerning its MARS Kit Gambro, Type 1116/1-X-MARS [Product code: 800540; Lot numbers (Expiration date): 22651 (01 September 2019), 22708 (30 September 2019)].
The manufacturer has received customer complaints regarding leakage in the albumin circuit. The leakage was caused by an inadequate adhesive connection of the tubing to the Hansen connector of the MARS Tube Set which is part of the MARS Treatment Kit.
According to the manufacturer, an undetected leaking albumin circuit could lead to excessive fluid removal from the patient during albumin dialysis. This could lead to hypovolemia. Delay or interruption of therapy may also occur if the issue is detected during priming. The manufacturer has not received any reports of adverse events or patient injury associated with this issue.
Affected users are advised to locate and remove all affected product from facility. Product recall is on-going.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 03 January 2018