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.
Medical device manufacturer, Medtronic, has issued a medical device safety alert concerning its Palindrome Precision Chronic Hemodialysis Catheters, Palindrome Chronic Hemodialysis Catheters, Mahurkar Chronic Carbothane Catheters [Product ID: 8888145015, 8888145016, 8888145017, 8888145018, 8888145040, 8888145041, 8888145042, 8888145043, 8888145044, 8888145040P, 8888145041P, 8888145042P; Multiple Lot Numbers] [HKMD No.: 200223].
According to the manufacturer, it has identified a potential leaking condition within the hub of specific chronic hemodialysis catheters during the production process. Flushing one extension tube may result in unanticipated fluid return through the adjacent extension tube (in addition to the anticipated flow of fluid through the distal tip of the catheter). The condition is the result of an inter-lumen void formed in the hub component of the catheter during the manufacturing process. During use, this observed condition could translate to cross-communication of the blood circuit. The affected products could introduce the potential for patient harm(s) including embolism, thrombosis, hemolysis, infection, and inadequate treatment. Replacement of an implanted catheter could introduce the potential for patient harm(s) including infection, delay to treatment/ therapy, and unintended radiation exposure due to the placement of an additional catheter.
The manufacturer advised affected users to immediately quarantine, discontinue use and return the affected products.
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 10 Jun 2022