X
OK Your changes have been successfully saved
SFDA Home Page
Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCAR Recall
Reference Number: mdprc 057 05 14 000
Date submitted: 5/13/2014
Manufacturer:Codan Argus AG
Device Type:Infusion pump CODAN ARGUS 717/718V
Description:Infusion pump, multifunction
Medical Device Identifier:Control software version 5.05
Reason of Field Safety Corrective Action:The basis of this Field Safety Notice are pertaining to the frequent Technical Errors #8123 and #8129 on CODAN ARGUS 717V infusion pumps. Technical errors #8123 and #8129 originate from the self-test of the down-stream pressure sensor. Analysis by the manufacturer revealed that apart from broken pressure sensors, excessive hardness of the intravenous infusion set could trigger these technical errors. The technical errors occur once the intravenous infusion set is inserted and the user closes the pump door - before the infusion is started.

Any such delay of infusion or interruption of therapy through a false infusion pump alarm, which may potentially put the patient’s health at risk, is unacceptable. Unanticipated variations of the mechanical properties of the intravenous infusion sets were identified as the root cause of above mentioned false technical errors.
Remedy Action:A forthcoming release of new pump control software will eliminate these false technical errors. Until this software release is available, customers are asked to ensure that the correct CODAN giving set is used and is fully compatible with the CODAN ARGUS 717V as per the manufacturer’s guidelines.
,br> Should a technical error occur whilst using a CODAN ARGUS 717V users should do the following:
1. Press the ON/OFF key to mute the alarm
2. Wait for five to ten seconds
3. Simultaneously press the two keys on the front of the pump to reset it.
4. Press the ON/OFF key to switch the pump on again:
a) If no technical error appears, continue to use.
b) If the previous technical error reappears, assume that a safety-relevant component is broken and switch to a substitute pump or gravity infusion.
Athorized Representative/Importer/Distributor:Al-Jeel Medical & Trading Co. LTD, Riyadh (011) 4041717
Report Source:NCAR
Source Ref. Number:CH-2014-05-12-041
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Vk_20140429_08-e1.pdf