Important Safety Alerts

The United States Food and Drug Administration (FDA) has issued a medical device safety alert concerning Alaris Medley Large Volume Pump (LVP) Frame Membrane, manufactured by CareFusion. The affected devices are identified as follows:

• Frame Membrane NOEM, Part Number: TC10006587 / 10013801 (Lot Number 022015502 and 0421151000)
• Frame Membrane NOEM Shipped with LVP Bezel Assembly, Part Number 49000204 (Lot Number 031815100, 032415100 and 043015215)
• Manufactured from: February 20, 2015 to April 21, 2015
• Distributed from: February 25, 2015 to May 8, 2015

The LVP is an infusion pump used to deliver fluids such as nutrients and medications into a patient's body in controlled amounts. The frame membranes are part of the pump that prevents fluids from leaking into internal components.

The supplier in the United States, Elite Biomedical Solutions, discovered that the use of this part can result in over or under infusion of fluids to the patient with the potential to cause patient injury or death.

Customers were instructed to take the following actions:

• Immediately examine the inventory and quarantine the affected product.
• The supplier will provide affected facility with a replacement part for each affected frame membrane, along with a label for product return.

For details, please refer to the TGA website:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm460137.htm
http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm460079.htm

If you are in possession of the affected products, please contact your supplier for necessary actions

Posted on 25 August 2015