FDA MedWatch - Alaris Medley Large Volume Pump (LVP) Frame Membrane by Elite Biomedical Solutions: Class I Recall - Frame Membrane May Allow Over or Under Delivery of Fluid by an Infusion Pump

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Title: FDA MedWatch - Alaris Medley Large Volume Pump (LVP) Frame Membrane by Elite Biomedical Solutions: Class I Recall - Frame Membrane May Allow Over or Under Delivery of Fluid by an Infusion Pump
MedWatch logoMedWatch - The FDA Safety Information and Adverse Event Reporting Program

Alaris Medley Large Volume Pump (LVP) Frame Membrane by Elite Biomedical Solutions: Class I Recall - Frame Membrane May Allow Over or Under Delivery of Fluid by an Infusion Pump

AUDIENCE: Risk Manager, Surgery, Critical Care Medicine, Nursing

ISSUE: 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. See the Recall Notice for a list of part and lot numbers.

BACKGROUND: The Alaris Medley Large Volume Pump (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. Infusion pumps are widely used in clinical settings such as hospitals, nursing homes, and in the home.

RECOMMENDATION: On May 21, 2015, Elite Biomedical Solutions sent their customers a Product Advisory Notices. On June 3, 2015, the firm sent their customers an Urgent: Medical Device Part Recall letters. And on June 12, 2015, a press release was issued via ECRI (Emergency Care Research Institute) to all hospitals in the US. In these communications, customers were instructed to take the following actions:

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Read the MedWatch Safety Alert, including a link to the Recall Notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm460137.htm


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