WalkMed Infusion LLC issues nationwide recall of Triton Pole Mount Infusion Pumps
Abstract:The Englewood, Colorado-based company said the recall covers those machines which were manufactured and sold before June 2010 and has serial numbers from 001 to 500 and also those from TR1401 to TR 2559.
Infusion pumps are used to deliver fluids -- nutrients and medications such as antibiotics, pain relievers and chemotherapy drugs -- in a controlled manner, and are widely used in hospitals and clinics.
WalkMed detected that the pump door alarms of these devices had the chance of failing to alert the user at the appropriate time, which can potentially cause over-infusion of medication into patients, therefore posing serious health hazards.
The company, however, said that no such accidents have been related till date and the FDA has said in a circular that any untoward incidents may be reported to its MedWatch Adverse Event Reporting program. It must be mentioned here that FDA’s Class I recall which is the highest degree of product recall refers to those products which can pose serious life risk to people.
The Triton Pole Mount Infusion Pump has been distributed to eight customers or distributors all over the country and the company said that five out of them have already been upgraded.
THE LEGAL HURDLE
Title 21 – Food and Drugs of the Code of Federal Regulations (CFR) is the primary regulation for medical devices, which has different sections dealing with various aspects of food, drugs, medical devices, and so on. Among these, 21 CFR 820, the Quality System Regulation, is the most important regulation for medical devises. Violation of this regulation can lead to monetary penalties and seizure of the product being recalled.
RELATED RECALLS
This recall of infusion pumps comes just three weeks after the FDA labeled the recall of CareFusion Corp.'s (NYSE:CFN) Alaris PC infusion units as Class I recall. This recall had covered approximately 17,000 CareFusion infusion units.
In September, Sigma International General Medical Apparatus, LLC similarly recalled its Sigma Spectrum Infusion Pump Model 35700 for reasons similar to the Triton Pole Mount Infusion Pump. In May also, the FDA had ordered Baxter International, a leading manufacturers, to "recall and destroy" all its Colleague brand pumps (approximately 200,000) in the US as the company had failed to ensure quality in spite of repeated notices.
REPORTING DETAILS
Consumers with questions on this product may contact the company directly at 1-303-420-9569 between 8:00 AM and 4:00 PM Mountain Time.
Source:
http://www.scribd.com/doc/37593891/Software-Testing-for-Medical-Devices
