Applix Smart & Applix Vision Nutrition Pumps Serial numbers from 1998xxxx to 2010xxx 에 대한 현장 안전성 서한

Field Safety Notice

SN2014(08)

2014-02-27

Ireland

HPRA

http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/applix-smart-applix-vision-nutrition-pumps-serial-numbers-from-1998xxxx-to-2010xxx&id=dd77f825-9782-6eee-9b55-ff00008c97d0

Fresenius kabi received an increasing number of complaints from the market about non-detected occlusions. as one possible influencing factor, a defective ball bearing was identified, potentially leading to a shift in the flow rate calibration values. fresenius kabi has been unable to locate all affected pumps that require an upgrade.

The IMB advises that users:  (1) The IMB recommends that users forward this safety notice to all those who need to be aware of this action within your organisation, including those who maintain pumps and to any other persons/organisations where these devices have been transferred.  (2) Identify the location of all affected pumps.  (3) If you / your institution have any affected pumps, please follow the manufacturer’s recommendations as outlined in the attached field safety notice and contact Fresenius Kabi.