Alaris GP, GP Guardrails, GP Plus & GP Plus Guardrails infusion pumps 의 안전성 경고

Safety alert

2013-06-11

2013-06-11

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20130611.html

Medical device safety alert: carefusion alaris gp, gp guardrails, gp plus & gp plus guardrails infusion pumps it has come to our attention that medical device manufacturer, carefusion, has initiated a field safety corrective action concerning its alaris gp, gp guardrails, gp plus & gp plus guardrails infusion pumps. the affected product references are 80263un01, 80263un01-g, 9002med01, and 9002med01-g, while the affected serial numbers involve those pumps manufactured between dec 2009 and jan 2012. through carefusion’s post market surveillance system, the manufacturer has identified an increased occurrence of stepper motor stalls in a proportion of the alaris gp, gp guardrails, gp plus & gp plus guardrails infusion pump population. the motor stall condition may occur during start up (immediately after the start key is pressed) or during an infusion which may result in the early termination of an infusion. in either case the pump is designed to fail safe giving an audible alarm, a visual alarm displayed on the infusion pump display - “drv1” or “drv2” and the red beacon light on the infusion pump will flash, prompting the infusion pump user to intervene. delay or early termination of an infusion could require intervention especially if critical drugs are being administered. carefusion is aware of several reports where motor stalls have occurred during an infusion but none have resulted in an undesirable clinical outcome. according to the manufacturer, stalls are due to the stepper motor’s front and rear bearings which may not perform as designed after a period of use. the manufacturer plans to replace all the motors of the affected pumps. until the motors can be replaced, users can continue to use potentially affected pumps in accordance with the directions for use. in the unlikely event that users experience a “drv1” or “drv2” error then they should take the pump out of service immediately and contact local carefusion representative. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 11 jun 2013.