Medical device manufacturer, Medtronic, has issued a medical device safety alert concerning its Covidien Palindrome RT chronic hemodialysis catheters. The details of affected products in Hong Kong are identified as follows:
The manufacturer reminds users of important information that is contained within the Instructions for Use (IFU) for Covidien Palindrome RT chronic hemodialysis catheters. In the last five years, the manufacturer has received reports of catheter and hub disconnections on Palindrome RT chronic hemodialysis catheters.
While the complaint rate for this issue is very low (0.013%) and the internal investigations have not identified a product deficiency or definitive root cause, the potential for patient harm, including air embolism and or hemorrhage, exists if users do not follow the IFU.
The manufacturer reinforces the information contained in the section entitled [CATHETER REVERSE-TUNNEL AND HUB/BACK END ASSEMBLY PROCEDURE] of IFU. Step 14 and Step 15, are the instructions for the hub and back end assembly. Clinicians who use the affected product are advised to familiar with these instructions.
"14. Align the "D-shaped" metal tubes of the hub/back end assembly with the internal lumens of the catheter tubing. [NOTE: Either orientation of the venous and arterial lumens is acceptable.] Pinch the catheter and advance it in short increments over the D-tubes and into the locking ring so that the metal D-tubes are completely covered by the catheter tubing. [CAUTION: Be sure the catheter end is advanced into the locking ring and seats fully against the hub.]"
"15. Advance the hub snap connector making sure to align the connector arms with the mating grooves on the hub/back end assembly. Snap the two components together making sure there is a tactile "click" and the connection is secure. [NOTE: Visually inspect the connection to ensure the connector arms are fully seated. If they are not, push the connector until both arms are fully seated.]"
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 24 September 2020