Plum A+ Family of Infusers 의 안전성 경고

Safety alert

2013-02-22

2013-02-22

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20130222.html

Medical device safety alert: hospira plum a+ family of infusers (battery not fully recharged) the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device 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 the manufacturer, error code e321 may occur while using a plum a+/a+3 infuser, this may lead to interruption of therapy. the e321 error code, which is accompanied by both an audible alarm and a visual error message on the infuser’s display, occurs when the device is operating ac power and the software detects that the battery could not fully recharged within eight hours. plum a+3, e231 alarms on one channel do not affect the other channels. if the e321 error code occurs during infusion, the infuser will stop delivery, which may result in a delay/ interruption in therapy. the severity in the delay or interruption in therapy is dependent upon the underlying condition of the patient and the treatment being prescribed. significant injury or death can be resulted. hospira revealed that the root cause of this issue is a degraded battery that no longer has the storage capacity to be fully recharged. mhra and hospira advised the affected customers to consider using an alternative device, particularly if an interruption to an infusion could compromise patient safety. if an alternative is not available, customers are advised to clear the error code by power cycle (turning off then on), and remove the infuser from service. while the infuser is out of service, it should be recharged according to the plum a+ system operation manual. if the e321 error code does not re-appear after the charging cycle, the infuser can be returned to service. if the e321 error code re-appears after the charging cycle, the battery should be replaced according to the plum a+ technical service manual and the infuser can be returned to service afterwards. furthermore, hospira will be deploying a new battery to address the problem. the mhra continues to investigate this and other recent field safety corrective actions relevant to the device. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/publications/safetywarnings/medicaldevicealerts/con239415 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 22 february 2013.