Medical device manufacturer, Medtronic, has issued a medical device safety alert concerning its MAHURKAR and Argyle Acute Hemodialysis Catheters. The affected Item Codes distributed in Hong Kong are identified as the following:
The manufacturer is notifying customers that the priming volume values printed on the affected products and Instruction for Use (IFU) are higher than the volumes required to fill each lumen.
In some instances, priming volumes for the affected products were established using the maximum calculated volume plus an additional volume to ensure the catheter was fully locked. This approach was chosen to ensure that the lumen is always fully primed, minimizing risk of catheter thrombosis. Therefore the printed priming volumes on current affected products and IFUs exceed the actual locking volume needed to fully fill each lumen. Depending on the catheter size and configuration, a variation from 0.1mL – 0.5mL per lumen from the printed priming value (actual locking volume would be lower) could be observed.
According to the manufacturer, lack of clarity on the printed priming volume could lead a clinician to administer more heparin than intended. Review of complaints since 2003 identified three complaints (out of approximately five million of insertions of the affected products) regarding catheter priming volumes. In one instance, the patient suffered a haematoma following heparin flush. No patient harm was reported in connection with the other two complaints.
The manufacturer is currently updating the IFU for the affected products to provide clarity on the currently printed priming volumes. In addition, to further improve the current labelling, the manufacturer is also re-evaluating the priming volume for all configurations and sizes of the affected products.
The affected users are recommended to use a non-heparinized lock solution, such as 4% sodium citrate, or 1000U/mL heparin to mitigate potential risk associated with unintended administration of additional concentrated heparin.
As per the IFU, the manufacturer re-emphasize its recommendations related to heparinization, and appropriate management of each individual patient's unique needs around coagulation. Specially,
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 3 May 2019