تسجيل الدخول
تسجيل جديد
الجمعة - شعبان 11, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
عن تيقظ
بحث عن منتج
تقديم بلاغ
أسئلة شائعة
تواصل معنا
EN
SA-20-01-26-1226
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Alaris VP Infusion Sets
الأجهزة المتأثرة
Please refer to the attachment for more details.
الممثل المعتمد
Becton Dickinson BV Saudi Limited Company
سبب المشكلة
The affected lots of Alaris™ VP Infusion Sets have the potential for fluid leakage from the silicone tube at the end of the pumping segment.
الإجراء التصحيحي
• Identify and quarantine all affected AlarisTM VP Infusion Sets. • Cease use of the affected product. • If devices have been safely used, no patient follow up activities are required • Make a note of the lot numbers and destroy all affected units. • Replace any impacted infusion set currently in use. • If the product is currently in use and you are unable to determine if it is within scope, continue to monitor for leakage or replace product. • When infusing hazardous substances (e.g. cytotoxics), prime the pump set with a nonhazardous fluid, wear appropriate Personal Protective Equipment (PPE) as per local hospital guidelines. Manufacturer's action: Removal.
المرفقات
عودة للقائمة
