Baxter has initiated a safety recall for its Spectrum Dose IQ Safety Software due to a potentially life-threatening defect in which incorrect drug-dosing information could be transmitted to the company’s Spectrum IQ Infusion System. The potential for patient harm is so serious, in fact, that the U.S. FDA has categorized it as a Class 1 recall.
Dose IQ was designed to smooth out the process of administering medications via the Spectrum IQ system. Healthcare providers program their own drug libraries into the software, along with dosing and delivery specifications, so that once a patient is connected to an infusion pump, they can automatically begin receiving the correct type and dosage of a medication with only the touch of a few buttons or by scanning a barcode.
In some cases, however, a defect in version 9.0.x of the software causes the information in those preprogrammed libraries to become mismatched, potentially causing improper configuration of requested medications. That misconfiguration, in turn, could lead to either a delay in treatment or an under- or over-infusion of medication.
So far, no injuries or deaths have been linked to the issue, but the FDA said it has received 15 complaints about the software to date.
Read the full article on Fierce Biotech.