تسجيل الدخول
تسجيل جديد
الجمعة - ذو القعدة 11, 1446
عن تيقظ
بحث عن منتج
تقديم بلاغ
أسئلة شائعة
تواصل معنا
EN
SA-19-08-24-563
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
BD Alaris™ System
الأجهزة المتأثرة
Product Name (REF No.): BD Alaris™ PCU (8015) BD Alaris™ SYR (8110) BD Alaris™ Pump (8100) BD Alaris™ PCA (8120) 147078-100 KIT IUI CONN (LEFT) 8XXX (N/A) Please refer to the attachment for UDI-DI and Serial No. Range.
الممثل المعتمد
Becton Dickinson BV Saudi Limited Company
سبب المشكلة
It has been identified an increase in bent contacts on Female/Left IUI connectors on the devices listed above.
الإجراء التصحيحي
The following labeling is in the process of being updated by BD: • BD Alaris™ System Maintenance User Manual v12.1.1 • BD Alaris™ System with Guardrails™ Suite MX For BD Alaris™ PCU Model 8015 and Alaris™ PCU Model 8015 Software Version 12.1.1 and Supported Modules Please follow the below actions to be taken by Clinical Users: 1. Per current labeling, customers should inspect all IUI connectors prior to use. a. Example images of defective pins are provided in Appendix 1 of the attachment. 2. In the event a bent Female/Left IUI connector is identified on affected serial numbers or parts, do not use the device and send the device to Biomedical Engineers or Qualified Service Personnel for repair.
المرفقات
عودة للقائمة
