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据2014年4月8日中国食品药品监督管理总局在其网站上发布公告称,美敦力公司因其生产的药物灌注系统可能会出现过量给药情况,决定对该产品进行主动召回。该药物灌注系统适用于需长期输入药物或液体的患者,中国共进口126台,目前已销售102台。过量给药是指输液速率超过标签上标识的程控输液速率14.5%以上,可能导致致命性剂量过高,还可造成由于给药泵过早排空而停药。美敦力公司称,根据相关报告,过量给药最早出现于药物灌注系统植入人体后5个月时;一旦给药泵过量给药,输液速率可能会继续加快,有时会突然加速。目前,导致过量给药的泵故障原因尚在调查中,还未确定故障与任何具体的泵批次、所用药
According to a notice released on its website by China Food and Drug Administration on April 8, 2014, Medtronic decided to take the initiative to recall the product because of the overdosage it may have in its drug infusion system. The drug infusion system for long-term input of drugs or fluids patients, China imported a total of 126 units, has sold 102 units. Overdosing refers to infusion rates exceeding the programmed infusion rate of 14.5% on the label, which can result in a fatal overdose and can result in withdrawal due to premature emptying of the dosing pump. According to Medtronic, Medtronic first appeared 5 months after the drug infusion system was introduced into the human body, and infusion rates could continue to increase and sometimes suddenly increase once the drug pump is overdosed. Currently, the cause of the pump failure that caused overdosing is still under investigation and the failure has not been identified with any specific pump batch, the medication used