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الخميس - صفر 27, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
عن تيقظ
بحث عن منتج
تقديم بلاغ
أسئلة شائعة
تواصل معنا
EN
SA-04-08-25-987
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Surdial X Dialysis Machine
الأجهزة المتأثرة
The following serial number ranges correspond to devices delivered with the affected Type 2 or Tуpе 3 Magnet Gear Pump P1: Surdial X Type A: 23DN1722~ 25DN2116 Surdial X Type B: 23DR0969~ 25DR1436 Surdial X Type C: 23DS11092~ 25DS15360 Surdial X Type D: 23EJ3361~ 25EJ5025 In addition, Surdial X machines that underwent maintenance or repair from 2023 onwards and received replacement parts using the order codes listed below are also considered impacted: SPARE PART; NIPRO ORDER CODE MAGNET GEAR PUMP UPDATE KIT; 0-704-349 MAGNET GEAR PUMP ASSEMBLY; 0-704-343 MAGNET GEAR PUMP; 0-704-341 PUMP BODY SET; 0-704-335
الممثل المعتمد
Al Faisaliah Medical systems
سبب المشكلة
An issue affecting Surdial X machines equipped with Type 2 or Type 3 Magnet Gear Pump P1 (Model Reference FG309XB0PX80814), following a number of complaints reporting dialysate flow errors and discoloration of the cut filter due to progressive mechanical degradation of the pump motor. Over time, this may lead to the introduction of fine particles or residues into the dialysate, which are typically retained by the cut filter - resulting in visible discoloration.
الإجراء التصحيحي
Where possible, it is advised to continue dialysis treatment on non-impacted dialysis machines. In case these are not available, the affected Surdial X machines may continue to be used for dialysis treatment. As there is a potential increase in nickel released by the pump, we advise you not to treat patients with a known nickel allergy active on these machines. Built-in safety systems remain and will notify users of any issues related to dialysate flow. In addition, the cut filter will continue to serve its purpose by capturing particles and protecting the patient from potential contaminants such as endotoxins and bacteria. The local representative of NIPRO CORPORATION will contact your facility to schedule the replacement of the affected Magnet Gear Pumps (Type 2 or Type 3), along with the cut filter. Please refer to the attachment for more details. Manufacturer action: Instructions and correction
المرفقات
عودة للقائمة