Baxter—Version 8.0 Master Drug Library Used with Version 8.0 SIGMA Spectrum Infusion Systems: Discrepancy between Loading/Bolus Default Dose Settings and Values Displayed on Pump May Exist

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In a March 5, 2015, Urgent Device Correction letter, Baxter states that there may be a discrepancy between the loading/bolus default dose settings in the MDL below and the values displayed on the infusion pumps below during loading/bolus dose programming. Specifically, when a drug's loading dose or bolus dose is configured in the MDL with a default starting time value in seconds, the loading dose or bolus dose setup screen on the pump will display the time value rounded to the nearest integer in minutes (e.g., 20 sec may be displayed as 1 min on the infusion pump display). Baxter also states that if this problem occurs, the pump will administer drugs as configured (the discrepancy is only with the default time on the setup screen, not with the amount or rate of drugs administered). However, if this problem is not detected or addressed before the drug library is used with the infusion pump, it may cause a delay in therapy or an unintended rate of delivery, potentially leading to serious adverse health consequences. Baxter states that this discrepancy occurs only on the above MDL version 8.0 used with the above infusion systems version 8.0 and that it has received no reports of adverse events associated with this problem. FDA's Center for Devices and Radiological Health (CDRH) states that the manufacturer initiated a correction by Urgent Device Correction letter dated March 5, 2015. FDA's CDRH also states that the manufacturer sent a follow-up Communication letter dated March 17, 2015, to provide additional clarification and instructions.

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