Medication Monitor

Generic Name (Trade Name—Company)
December 9, 2011

Patient-monitoring system

(Infinity Acute Care System Monitoring Solution—Draeger Medical)
Medical device recalled because of incorrect drug calculations

An unusual Class I recall involves a medical device that incorrectly calculates weight-based drug dosages and improperly displays certain cardiac parameters. All serial numbers of the Infinity Acute Care System Monitoring Solution are being recalled, according to a FDA news release. The product was only distributed to Rush University Medical Center in Chicago.

Specifically, the weight-based drug dosage calculation may indicate incorrect recommended values, including a drug dosage up to 10 times the indicated dosage. In addition, there may be a 5- to 10-second delay between the electrocardiogram and blood pressure curves at the Infinity Central Station.

In October, the manufacturer had advised the clinicians at Rush University Medical Center to enter the patient’s weight on the admin/demographics screen to ensure the drug dosage is calculated as intended. In addition, the manufacturer recommended that primary monitoring and diagnosis of bedside patients be done via a bedside monitor and that the Infinity Central Station only be used for remote assessment of a patient's status.