Field Corrective Action R-2021-004 : NEXADIA monitor - Software Update

 

 

Affected Medical Device : NEXADIA monitor Set

 

MDA Reference Number : MDA/FCA/2021-P161

 

MDA Registration Number : GMD34519448418A

 

Decription :

During comprehensive internal testing, we became aware that in case a customer deviates from the instructions for use of NEXADIA monitor and performs a session data import manually from an external database to NEXADIA monitor in addition to the already automatically performed initial data import, medication, checklist entries and messages can be displayed incorrectly in NEXADIA monitor or by a connected dialysis machine.

 

Local Establishment Contact Detail :

Winnie Hii Lin Lin
Senior Executive, Regulatory Affairs
Tel: 03 - 78414200
Crown Penthouse,Plaza IBM,8, First Avenue,Persiaran Bandar Utama,47800 Petaling Jaya,Selangor,Malaysia.
http://www.bbraun.com

 

Email : winnie.hii@bbraun.com