Medical device manufacturer, Baxter Healthcare Corporation, has issued a medical device safety alert concerning its ARTISET Blood Tubing Sets. The affected devices are identified as follow:
- A) ARTISET HD DNL HC [Product Code: 955075]
- Lot Number: 1000198911, 1000198938, 1000198944, 1000203372, 1000204788, 1000204791, 1000204792, 1000204800, 1000205908, 1000205916, 1000205920, 1000206883, 1000206885, 1000206887, 1000208232, 1000208233, 1000208239, 1000210341, 1000210342, 1000218865, 1000220508, 1000220509, 1000220510, 1000220511, 1000220513, 1000220516, 1000220518, 1000223068, 1000224759, 1000224760, 1000224761, 1000225445, 1000225446, 1000226695, 1000226700, 1000226702, 1000226704, 1000226705, 1000226708, 1000229610, 1000229615
- B) ARTISET PREPOST [Product Code: 955077]
- Lot Number: 1000198924, 1000198955, 1000204804, 1000206880, 1000206882, 1000208251, 1000210325, 1000210326, 1000216200, 1000221645, 1000226119, 1000226121, 1000226690, 1000226692, 1000229608, 1000232235
- The affected lots have been distributed since 1 Aug 2018 in Hong Kong.
The manufacturer has received customer complaints of various disconnection events with Artiset Blood Tubing Sets. The issue has been isolated to a subset of lots, based on production dates. Currently, there are no alternative suppliers of this product; the product quality issue can be detected during set-up or priming of the device.
According to the manufacturer, a disconnection event may result in blood loss, air embolism, or delay in therapy. There has been no reports of serious injury related to blood loss as a result of disconnection in Hong Kong.
The manufacturer has implemented corrective actions to mitigate the occurrence of disconnections in newly manufactured sets. The manufacturer is asking that users to perform product inspections to check the sets for disconnections prior to use to minimize the disruption of required hemodialysis treatments.
Affected users are advised to take the following actions:
- Operators may continue to safely use affected sets if no detachments are observed. Prior to use, thoroughly inspect each connection of the set to check for any detachments in the tubing. Additionally, per the Instructions For Use, they should observe carefully for leaks during priming and use, and examine the tubing carefully to be certain that all connections are secure, all lines are unobstructed and that there are no kinks or leaks in the tubing.
- If they find sets with tubing disconnections, contact the local sales representatives to arrange for return and replacement.
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 29 April 2020