Baxter Dose IQ

2021: Withdrawal of defective infusion pump software

In mid-August 2021, it became known that it Baxter was withdrawing ON the Baxter Dose IQ defective for infusion pumps. Regulators USA assigned class I to the recall, designating it as the most serious type of recall, that is, defective software can lead to the development of serious health disorders or death.

Baxter developed its Dose IQ security software as a standalone computer program that allows doctors to create a drug library with predefined dose information for specific drugs. The Spectrum IQ infusion pump then uses this library of drugs and dosages for controlled administration to a patient, taking into account individual characteristics such as body weight and sex.

The recall was related to a software defect that could lead to a mismatch between the drug information received by the infusion pump and the information that was introduced into the drug library using the Baxter Dose IQ 9.0 software version.

Baxter withdraws defective infusion pump software that can lead to the development of serious health disorders or death

According to regulatory notification, physicians should check if the drug ID in the program matches the drug information on the infusion pump display. Due to a software error, the infusion pump may misinvent the drug with the development of serious side effects. Including delayed therapy, insufficient or excessive infusion of the drug. As of mid-August, the company received 15 complaints related to defective software, but no injuries and fatalities were reported in connection with this error.

Devices affected by the recall include the product code 35723V091 and were sold between February 1, 2018 and January 1, 2019. In total, since the release of the recall on July 7, 2021, the company has recalled 61 devices.^[1]

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