Baxter Reinforces Guidance Regarding Urgent Medical Device Correction for Exactamix Pro Due to Software Overfill Error
迪尔菲尔德中学,生病了. -
百特国际有限公司. 正在加强关于紧急医疗器械纠正的指导 ExactaMix职业 1200年和 ExactaMix职业 2400复合使用软件版本2.0.8和2.1.8. Baxter notified impacted customers initially in December 2023 和 again in February 2024. 更正是由于“使用一些过度填充”功能中的错误, 哪一种成分可能会过量进入最终混合物. Baxter expects to release a software upgrade to resolve the issue in March 2024. 目前还没有与此问题相关的伤害报告.
ExactaMix职业 1200年和 ExactaMix职业 2400台是药学实践中使用的自动配药系统. Compounding refers to the process of combining or mixing ingredients to create a medication tailored to the needs of the individual patient. 在软件版本2中发现的错误.0.8和2.1.8 while using the "Use Some Overfill" feature may lead to over-delivery of an ingredient into the final admixture. This issue can result in redundant ingredient delivery of the requested overfill volume. Unintended over-delivery of an ingredient during compounding into the final admixture may lead to serious adverse health consequences including death or permanent disability.
修正适用于的特定子集 ExactaMix职业 1200(产品代码EXM12DY)和 ExactaMix职业 2400 (Product Code EXM24DY) compounders in the United States using software versions 2.0.8和2.1.8. 虽然客户可能会继续使用 ExactaMix职业 compounders, it is important to implement safeguards until the software solution is deployed. The following reinforced guidance is provided by Baxter for those customers who continue using the ExactaMix职业 混合者:
- 当系统显示原料耗尽时, operators should choose to "Swap Container" or "Use a Different Container" 和 not utilize the "Use Some Overfill" feature until the software solution has been implemented. For additional guidance on these alternatives to using the "Use Some Overfill" feature, 请参考文档第82-83页的“替换源容器” ExactaMix职业 2400操作手册和第83-84页 ExactaMix职业 1200操作手册.
- If the "Use Some Overfill" feature is inadvertently used, operators must ensure that:
- The "Use Some Overfill" feature is used only once when an ingredient is depleted.
- 当提示时输入过填量即可使用, 输入小于“交换容器”窗口中规定的剩余要运行的卷.
- 在 MixCheck 报告, verify that all ingredient deliveries that used overfill volume delivered the expected ingredient volume. 要做到这一点, users should make a line-by-line comparison of each ingredient's dispensed 和 ordered volume 和 should also ensure that the final total volume for the bag aligns with the expected volume.
- 如果你观察到多余的成分输送使用过填充量每 MixCheck 报告，丢弃袋子.
- 经常复习期末考试 MixCheck 中描述的报告 ExactaMix职业 操作手册. 请在第167-171页查阅有关此功能的信息 ExactaMix职业 2400操作手册和第164-168页 ExactaMix职业 1200操作手册.
Customers with additional questions can contact their Baxter sales representative, or Baxter Global Technical Services at 800-678-2292 Monday through Friday between 8 a.m. 7分.m. 东部时间. Any adverse events experienced with the use of this product may be 报告ed using one of the following options:
- Contact Baxter Product Surveillance by navigating to the Baxter Product Feedback Portal at http://productfeedback.ladbrokes立博体育.com 或电子邮件 (电子邮件保护).
- 向FDA MedWatch不良事件报告项目报告:
- 网上:在网上填写并提交报告 http://www.accessdata.fda.gov/scripts/medwatch/.
- 普通邮寄或传真:从以下网址下载表格 www.食品及药物管理局.gov /提交确证/ getforms.htm 或致电800-332-1088索取报告表格, then complete 和 mail it to the address on the pre-addressed form or submit by fax to 800-332-0178.
百特是在知情的情况下自愿发布这一信息的.S. 美国食品药品监督管理局.
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