On December 11, 2024, Nuwellis Sent A Notice To Affected Customers That It Is Voluntarily Recalling Specific Lots Of AquaFlexFlow UF 500 Plus Extracorporeal Blood Circuit Which Is Used With The Aquadex Smartflow Or Aquadex Flexflow System - Filing
On December 11, 2024, Nuwellis Sent A Notice To Affected Customers That It Is Voluntarily Recalling Specific Lots Of AquaFlexFlow UF 500 Plus Extracorporeal Blood Circuit Which Is Used With The Aquadex Smartflow Or Aquadex Flexflow System - Filing
The lots are being recalled due to failures of the blood circuit associated with too many mismatch alarms. The blood circuits may indicate "Ultrafiltrate Weight Mismatch" or "Excessive Weight Mismatch" alarms while in use. If not addressed, this failure could result in excess fluid removal from a patient leading to Acute Volume Depletion.
由於與過多的不匹配警報相關的血液迴路故障，這些批次正在被召回。在使用期間，血液迴路可能會出現 "超濾液重量不匹配" 或 "過量重量不匹配" 的警報。如果不加以處理，這種故障可能會導致患者體內液體過度移除，進而導致急性體積耗竭。
As of the date of this Current Report on Form 8-K, the Company is aware of five reported incidences of blood circuit product failures, with three leading to patient dehydration and requiring administration of fluids.
截至本當前報告（8-K表格）日期，公司已知有五起血液迴路產品故障的報告事件，其中三起導致患者脫水，並需要輸液。
The recall is being conducted with the knowledge of the U.S. Food and Drug Administration which has not yet characterized the Class of the recall.
此次召回是在美國食品和藥物管理局的知情下進行的，該局尚未對召回的類別進行分類。
譯文內容由第三人軟體翻譯。
