MalfunctionKDI
PRISMAFLEX ST 150
Received Mar 20, 2026 · Event occurred Mar 12, 2026
Report MW5185515 · MDR key 24651124
Device
Generic name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Manufacturer
Baxter Healthcare, S.a.Model number
ITM-40191580Lot number
25C0037CA
Product problems
- Activation Problem
Patient
80 YR · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
BAXTER CRRT TUBING MALFUNCTION, STAFF RECEIVED AN ERROR MESSAGE WHEN TRYING TO LOAD INTO MACHINE. NO PATIENT HARM. STAFF ATTEMPTED WITH 3 SETS PRIOR TO GETTING ANOTHER LOT NUMBER. THE NEW LOT NUMBER WORKED. THE DEVICES WITH THE SAME LOT NUMBER CAUSING THE ERROR WERE SEQUESTERED. LOT NUMBER WITH ERROR MESSAGE: 25C0037CA. PT CODE: 4582. DEVICE CODE: 4042. REFERENCING REPORTS: MW5185513 AND MW5185514.