Important Safety Alerts

Medical device manufacturer, Baxter, has issued a medical device safety alert concerning its Prismaflex Control Unit [Product Code: 106913, 107493, 103082, 113874, 114489, 114870, 966052; Serial Number: All].

According to the manufacturer, there are questions from clinicians who are exploring modifying the use of Prismaflex control units, in order to minimize exposure to COVID-19 positive patients. For example, clinicians may be using multiple extension lines to extend the length of the tubing set to allow placement of a Prismaflex control unit outside of the patient's room. There are several significant risks that arise with this practice.

To mitigate these risks, users are asked to follow the setup instructions in the Graphical User Interface and the warnings from the Prismaflex Operators Manual, otherwise serious patient harm may occur.

"WARNING: Always connect the return line directly to the blood access device. Do not connect additional devices between the return line and the blood access device. The use of additional devices, such as three-way valves, stopcocks or extension lines, may impair return pressure monitoring. Their use can impede the detection of return disconnections, potentially resulting in severe blood loss."
G5036005 version 7.xx OM (p.16, 50, 146)
G5036007 version 8.xx OM (p.26, 63, 164)

"WARNING: During priming and operation, observe the system closely for leakage at joints and connections within the set. Leakage can cause blood loss or air embolism. If leakage cannot be stopped by tightening the connections, replace the set."
G5036005 version 7.xx OM (p.16)
G5036007 version 8.xx OM (p.25)

The following hazards are associated with the use of multiple extension lines to allow placement of a Prismaflex control unit outside of the patient's room:

• The manufacturer cannot guarantee that the use of multiple extension lines will establish and maintain secure connections with Prismaflex sets. The use of extension lines could increase the risk of disconnections and interfere with the ability of the Prismaflex control unit 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.
• Additionally, the use of extension lines increases the blood in the extracorporeal circuit.
• In the event of non-restitution or clotting of the circuit, this may lead to blood loss beyond what is tolerable for the patient.
• Other potential risks include hypothermia, air embolism, and infections.

There have been no reports of complaints or serious injury related to this issue in Hong Kong. According to the manufacturer, operators can safely use the Prismaflex control units when adhering to the product specific Operators Manual and Graphical User Interface.

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 1 April 2020