A Draeger Medical Inc. acute patient monitoring system faces a class I recall as the device might give drug dose calculations 10 times higher than recommended, the Food and Drug Administration said Tuesday.
The FDA said the device, the Infinity Acute Care System Monitoring Solution (M540), was only shipped to Rush University Medical Center, a 676-bed hospital in Chicago. Shipping dates were from July 1 to Sept. 30.
The FDA said the reason for the recall was that the device's weight-based dose calculations could show "incorrect values." Also, there was a delay in some vital signs at the Infinity Central Station, a remote assessment station, which can be used with the device.
Draeger, in an Oct. 17 letter sent to Rush, advised entering the patient's weight on the device's admin/demographics screen to ensure correct calculations. It also said to use the bedside monitor for primary patient monitoring.
Draeger's international headquarters is in Lubeck, Germany.
