Plum A+ Family of Infusers 의 안전성 경고

Safety alert

2013-02-21

2013-02-21

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20130221.html

Medical device safety alert: hospira plum a+ family of infusers (distal occlusion pressure sensor drift) the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning plum a+ family of infusers manufactured by hospira uk limited. the affected list numbers are: 11005 (plum a+ hyperbaric infusion system) 11971, 12391 (plum a+ single channel infusion system) 12348, 12618 (plum a+3 infusion pump system) 20678 (plum a+3 infusion pump with hospira mednet software) 20792 (plum a+ infusion pump with hospira mednet software) according to hospira, the distal pressure sensor calibration may have drifted on plum a+ infusers. if this issue happens, the following error codes maybe displayed during setup or infusion: e251, n251, e345, or e346. additionally, customers may also experience early or late distal occlusion alarms. hospira further explained that if distal pressure sensor calibration drift occurs, the pump may not sense the build-up of pressure and will not alarm when occlusion thresholds are exceeded. this full or partial occlusion may prevent fluid from reaching the patient and may result in either a delay/interruption of therapy and/or underdose, which has a worst case potential to result in significant injury or death. if this situation results in late distal occlusion alarms, excessive pressure and fluid may build up within the distal line undetected by the pressure sensor. when the distal occlusion is resolved, the built up fluid will be administrated into the patient possibly causing an overdose. overdose has the potential to result in significant injury or death. the manufacturer advises users that: they should check the technical service manual to determine if pressure drift has occurred. if the issue continues to occur and is confirmed through pvt, they should remove the device from service and contact local hospira office. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/ fieldsafetynotices/con234577 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 21 february 2013.