More on leaking ports with ExactaMix 2400 compounder
ISMP has received reports of leaking EXACTAMIX 2400 valve set ports beyond the issues that Baxter mentioned in its July 14, 2022, Urgent Medical Device Correction communication. Baxter had previously received complaints of ports 1 and 2 leaking when in the closed position, resulting in unintended ingredient transfer into the compounded admixture. Baxter has focused on ports 1 through 4 for device corrections; however, we recently received reports from a hospital involving leaking ports beyond 1 through 4. We have shared this with Baxter. While these events may be due to using the device incorrectly (e.g., wrong syringes or vial sizes), we do not know if the other ports are leaking due to manufacturing issues like those previously reported. Baxter is investigating these additional reports, and the root cause of the suspected problem is currently unknown. Because parenteral nutrition (PN) ingredients are often colorless and the vials on automated compounders are replaced infrequently, practitioners are unlikely to identify individual small-volume ingredient discrepancies, which could result in patients receiving incorrect admixtures. In addition, we received a report regarding a missing valve in the valve set (Figure 1).
To prevent inaccuracies due to device setup, always use BD 50 mL syringes and medication vials that are 10 mL or larger, per the Operator Manual. As Baxter investigates the recent reports, periodically observe the pumping process and the ingredient source container levels to ensure their volumes are not consumed faster than expected. When replacing a valve set, visually check that all valves are present. Report all incidents to FDA, Baxter, ECRI, and ISMP. When reporting to Baxter, follow the instructions outlined in the field action letter and hold the suspect unit(s) until you receive instructions from Baxter. Our affiliate and safety partner, ECRI, published an ECRI Hazard Report.