According to an online news report on fiercebiotech.com, Baxter has initiated a recall of its “Dose IQ” software made for its Spectrum IQ infusion pump after it was found to cause dangerous adverse events. Baxter has reported that a defect was found in its Dose IQ software can transmit incorrect drug dosing information to its Spectrum IQ infusion pumps. If this occurs, the patient could be at risk for injury or severe adverse events, including death. This week, the FDA designated this recall as Class I recall, which is the FDA’s most serious recall ratings, indicating a probability of serious injury or death to users.
Dose IQ was created to ease the method of dispensing medications via the Spectrum IQ system. The system enabled healthcare providers to program their own drug libraries into the “Dose IQ” software, along with the delivery and dosing specifications. This way, patients connected to an infusion pump will automatically receive the correct medication and dosage by scanning a barcode or by pushing a few buttons.
However, a defect in the product’s software (version 9.0.x) can cause the data in the preprogrammed libraries to become mismatched. This can cause an improper configuration of medications. That misconfiguration could cause a delay in treatment or administer an over- or under-infusion of medication.
The FDA reported that the agency had received 15 complaints concerning software issues. Medical professionals are being asked to pay attention to their infusion pumps’ preprogrammed delivery and dosing information. Should the incorrect configuration show up on the pump, the user should report the incident to their pharmacy department and then manually program the pump while in basic mode.
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