Syringe Pump Green Stream SY-P ARGUS 600 and Argus 600 의 안전성 경고

Safety alert

2014-11-25

2014-11-25

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20141125.html

Medical device safety alert: codan argus syringe pump green stream sy-p argus 600 and argus 600 the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning syringe pump green stream sy-p argus 600 (firmware version 1-.00-1.51) and argus 600 (firmware versions 3.01-4.32) manufactured by codan argus ag. the safety alert is about a missing pump alarm caused by incorrect pump maintenance. argus 600 was produced in three firmware (fw) versions: version fw1: green stream sy-p argus 600, firmware version 1.00 - 1.51. version fw3 and fw4: argus 600, firmware version 3.01 - 4.32. investigation of an adverse event revealed that fw3/fw4 clamps were used in one european hospital as replacements for broken fw1 clamps resulting in the “syringe alarm” not activating - even though the syringe was mounted improperly it was possible to start the infusion. the manufacturer clarified that the differences between codan argus 600 version fw1 and version fw3/fw4 included mechanical, electronic and further logical changes. as there are design differences between fw1 and fw3/fw4, several mechanical parts inside the driver head are not interchangeable across the fw versions - although they are of a similar shape. the manufacturer is sending a customer letter, user manuals and service manuals to the affected users. as lack of infusion control or delay of therapy is associated with the risk of under infusion of medication with a potential harm of pain, serious injury or death to patient, customers are advised to check the compatibility of firmware and clamps by visual inspection and follow the corrective actions stated in the safety alert. for details, please refer to the following link: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con475305 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 25 november 2014.