Infusion pump CODAN ARGUS 71XV and Syringe pump CODAN ARGUS 606S 의 안전성 경고

Safety alert

2014-09-30

2014-09-30

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20140930a.html

Medical device safety alert: codan argus infusion pump codan argus 71xv and syringe pump codan argus 606s the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning infusion pump codan argus 71xv (control software version 5.06) and syringe pump codan argus 606s (control software version 4.80 and 4.81), manufactured by codan argus ag. during internal development testing, the manufacturer has detected a potential software issue regarding the serial communication interface implementation of codan argus 71xv and codan argus 606s. both models have a serial communication interface supporting data retrieval of device and infusion information for storage in patient data management systems (pdms) or similar systems. due to this potential software issue, technical error 2401 (a606s) or 8001 or 8124 (a71xv) may occur on pumps integrated in such systems. a technical error will stop the running infusion, put the pump in a safe mode, and trigger an acoustic and visual alarm. technical errors should be resolved by restarting the pump, re-entering delivery parameters and restarting the infusion. the interruption and delay of therapy is associated with the risk of under infusion of medication with a potential risk of pain, serious injury or death. the manufacturer has corrected the issue within the pump control software revisions, namely codan argus 71xv, version 5.07 and codan argus 606s, version 4.82. the manufacturer advises that implementation of this software upgrade is mandatory across all units mentioned which are connected to a patient data management system (pdms) or similar system. these are available from the manufacturer’s web server. after each firmware upgrade it is necessary to perform the safety standard check. for details, please refer to the following link: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con457620 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 30 sep 2014.