Important Safety Alerts

Medical device manufacturer, Baxter, has issued a medical device safety alert concerning its Prismaflex Control Unit. The affected devices in Hong Kong are identified as follows:

• Prismaflex Control Unit [Product Code: 106913, 107493, 113082, 113874, 114489, 114870 and 955052; Serial Numbers: All]
• Preventive Maintenance Kit [Produce Code: G5010007; Serial Numbers: All]
• ARPS Pump Segment Kit [Produce Code: G5064801; Serial Numbers: All]
• ARPS Pump Assembly [Produce Code: G5006203; Serial Numbers: All]

According to the manufacturer, due to variability in the performance of the tubing in the ARPS (Automatic Repositioning System) Pump Assembly, which may lead to the following alarm situations during or after a system self-test. Primary alarms may experience "Malfunctions: Prime Self-Test Failure (Code 4) during priming" or "Malfunction: Self-Test Failure (Code 4) during treatment". Secondary alarms may experience "Caution: TMP Excessive" or "Advisory: TMP Too high"

The Prismaflex Control Unit performs system self-tests during priming and at defined intervals during therapy. Therefore, the above alarm situations may occur during priming or during treatment. In these alarm situations, the Prismaflex Control Unit will default to a safe state and provide on-screen instructions to the user. Affected users should follow the on-screen instructions if an alarm appears.

If an alarm occurs, it may lead to delay or interruption of therapy. If therapy is terminated without returning blood to the patient, blood loss may occur. To date, there have been no reports of serious injury potentially associated to this issue in Hong Kong.

To prevent potential alarm situations, the tubing in the ARPS Pump Assembly for the Prismaflex devices will be replaced with improved tubing.

• Operators may continue to use the Prismaflex Control Unit according to the instructions in the Operator's Manual until the tubing is replaced within the ARPS Pump Assembly.
• If an alarm occurs, the Prismaflex Control Unit will default to a safe state and the user should follow the on-screen instructions.
• Existing pump segments and pump assembly kits in their inventory may be utilized for critical repairs until the improved tubing is provided to their facility. If affected users need additional parts, they should communicate their repair needs to their local Technical Service representative and the manufacturer will prioritize replacement kits when they are available. If the repairs are not urgent, affected users may wait to perform the repairs until Baxter contacts them to arrange for the replacement of these products.
• The tubing in the ARPS Pump Assembly is normally replaced during annual Preventive Maintenance (PM). If the Prismaflex Control Unit is due for PM, these activities should be delayed until new kits have been provided.

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 action.

Posted on 4 February 2021