Potential risks identified with the Alaris System. CareFusion Corporation, which is expected to become a public company following its planned spin-off from Cardinal Health, just issued an update to its previously disclosed recall of the Alaris System, said the U.S. Food and Drug Administration (FDA).
On June 12, 2009, the company sent an urgent Medical Device Recall Notification to customers of its Alaris® System addressing potential risks identified with the Alaris System. The affected devices have one or more failures associated with the Occlusion Warning Message, Syringe Volume Warning Message, Electrostatic Discharge protection circuitry, and Fluid Ingress into the device’s pumping mechanism.
This recall also updates the labeling for the Inter Unit Interface (IUI) connectors on the Alaris® System. According the FDA, the potential risks may lead to improper infusion therapy, which could cause serious adverse health consequences or death.
CareFusion’s short-term instructions
Serial numbers of affected devices, CareFusion’s short-term instructions to customers, and the firm’s strategy to fix the affected devices can be found at: www.cardinalhealth.com/alaris/medical-device-recall/.
Also, following the FDA’s 510(k) clearance of the firm’s software correction in July 2009, CareFusion is now implementing corrections for units in the field.
CareFusion also began sending customers using the Alaris Patient Controlled Analgesia (PCA) module an update to the June 12, 2009, Medical Device Recall Notification. That update contains an additional required action to mitigate potential risk before completion of the field corrective action related to the Syringe Volume Warning Message that may appear while using the Alaris PC unit with the Alaris PCA module.
The additional step involves removing the patient-controlled dose request handset from the patient prior to reprogramming the infusion pump.
Customers should follow steps, says FDA
In the interim, the FDA said customers should follow steps outlined in the June 12 Medical Device Recall Notification and the updated Notification for customers using the Alaris PCA module to minimize potential risk before implementation of the software and hardware updates.
CareFusion notified customers by registered letter on June 12, 2009, posted the customer letter on the company’s Web site, and set up a dedicated call center for customer support, said the FDA. The June 12 letter can be accessed (in PDF format) at: http://www.legacycarefusion.com/alaris/brochure/Customer%20Letter%20-%20Signed.pdf
The FDA is also asking that any adverse reactions experienced with the use of this product, and/or any quality problems should also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088; by Fax at 1-800-FDA-0178; by mail at MedWatch, HF-2, FDA 5600 Fishers Lane, Rockville, MD 20852-9787; or online at www.fda.gov/medwatch.
Customer inquiries should be addressed to the CareFusion recall center, tool-free, at 1-888-562-6018.