A Class I recall has been issued for the Draeger Patient Monitor, the U.S. Food & Drug Administration (FDA) just announced. A Class I recall is the FDA’s most serious designation and involves a situation in which there is a reasonable probability that the use of, or exposure to, the recalled, violative product will cause serious adverse health consequences or death.
All serial numbers for the Infinity Acute Care System Monitoring Solution (M540), Catalog number MS25510, are affected by this recall. Draeger Medical, Inc. (3135 Quarry Road, Telford, Pennsylvania, 18969-1042) issued the recall of the Infinity Acute Care System Monitoring Solution (M540), which was manufactured by Draeger Medical GmbH Moislinger Allee 53-55 23558 Lubeck, Germany.
This recalled Infinity Acute Care System Monitoring Solution (M540) was manufactured from March 1, 2011 through September 30, 2011 and distributed only to the Rush University Medical Center in Chicago, Illinois, from July 1, 2011 through September 30, 2011.
The FDA pointed out that on October 17, 2011, Draeger Medical, Inc. sent the Rush University Medical Center a letter stating that users should enter the patient’s weight by way of the admin/demographics screen to ensure the drug dosage is calculated as intended. Also, Draeger Medical’s letter states that users should follow the Instructions for Use of the Infinity Acute Care System Monitoring Solution. Instructions for Use include, “For primary monitoring and diagnosis of bedside patients, use the bedside monitor. Use the Infinity Central Station only for remote assessment of a patient’s status.”
The Infinity Acute Care System Monitoring Solution (M540) is a networked solution system used to monitor a patient’s vital signs and therapy, control alarms, review Web-based diagnostic images, and access patient records. The number of monitored vital signs can be increased or decreased based on the patient’s needs.
The weight-based drug dosage calculation may indicate incorrect recommended values, including a drug dosage up to ten times the indicated dosage. Additionally, there may be a 5-10 second delay between the electrocardiogram and blood pressure curves (waveforms) at the Infinity Central Station. Because of this, the Infinity Acute Care System Monitoring Solution (M540) recall has been deemed a Class I.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail, or by FAX. Information on the program is accessible at: http://www.fda.gov/Safety/MedWatch/default.htm. Draeger Medical, Inc. can be reached at 1.215.660.2349.