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].

The manufacturer informs important safety information regarding the use of connectors with the Prismaflex system. The use of connectors may prevent a secure connection between the return line and the patient's blood access device. To ensure a proper connection, users must follow the Prismaflex Operator's Manual, which lists the following warnings:

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 manufacturer cannot guarantee connectors will establish and maintain secure connections with Prismaflex sets. Additionally, use of connecting devices with the Prismaflex Control Unit could 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. There has been no reports of product complaint and adverse event associated with this issue in Hong Kong.

Operators may continue to safely use the Prismaflex control units according to the warnings and cautions in the Operator's Manual.

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 13 February 2020