Medical device manufacturer, Baxter Healthcare Ltd, has issued a medical device safety alert concerning its following products:
The manufacturer is communicating important safety information regarding the use of connectors between the patient's blood access device and the Baxter blood set used with the Baxter dialysis machines listed. The manufacturer has not validated the use of any connectors placed between the blood set and the patient's blood access with Baxter dialysis machines. The use of connectors with potentially incompatible material may increase the risk for leakage in the extracorporeal circuit and may prevent a secure connection between the blood set and the patient's blood access device.
Furthermore, introducing additional components in the blood circuit may cause additional pressure drops and may affect the pressure measurement in the blood circuit. The manufacturer cannot guarantee connectors will establish and maintain secure connections with Baxter blood sets. Additionally, use of connecting devices with Baxter dialysis machines could interfere with the ability of the device to accurately detect pressure drops in the blood circuit. As a result, vascular access disconnects may go undetected, leading to clinically significant blood loss and fatal exsanguination. There have been no reports of complaints or serious injury related to this issue in Hong Kong.
To ensure a proper connection, users must follow the warnings and cautions listed in the product-specific Operator's Manuals. According to the manufacturer, operators may continue to safely use Baxter dialysis machines according to the instructions, warnings, and cautions in the product-specific Operator's Manuals.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 17 November 2020