Draeger Medical’s Infinity Acute Care system, used to monitor patient vital signs and therapy, got a Class I recall from the FDA over concerns that its weight-based drug dosage calculator may make dangerously high recommendations.
The system may even recommend a dose as much as 10 times higher than that the safe amount, and "may cause serious adverse health consequences, including death," according to the FDA.
In addition, the Infinity system’s electrocardiogram and blood pressure monitors may displaying DATA with a 5 or 10 second delay.
The German company sent a letter mid-October warning health care providers at Rush University Medical Center in Chicago that the system may behave inconsistently unless primary monitoring and diagnosis of bedside patients was done at the bedside monitor and remote assessment is conducted at the device’s central station.
Class 1 recalls signify the most serious types of device issues, involving situations with a reasonable probability that continued use will cause serious injury or death.