Description of Event or Problem · 0
MULTIPLE CASES OF COAGULATION IN PATIENTS DURING TREATMENT. ACCORDING TO THE STAFF, THERE HAVE BEEN NO RECENT CHANGES IN CONSUMABLES OR MEDICATIONS. CTA DIALYZERS HAVE BEEN IN SUE FOR AN EXTENDED PERIOD. AFTER COAGULATION OCCURRED, CLINICAL TEAM INCREASED ANTICOAGULANT DOSAGE BUT NO IMPROVEMENT, REQUIRING REPLACEMENT OF THE DIALYZER. EXACT DATE OF EVENT IS UNKNOWN. EVENTS OCCURRED BETWEEN DECEMBER 2025 THROUGH JANUARY 2026. DEVICE CODES IN QUESTION: 1. FB-15U, LOT# 25J02D, MANUFACTURING DATE: 10/02/2025, EXPIRY DATE: 09/30/2028 (TOTAL (B)(4). 2. FB--17U, LOT# 25H25D, MANUFACTURING DATE: 08/25/2025, EXPIRY DATE: 07/31/2028 (TOTAL (B)(4). ADDITIONAL INFORMATION RECEIVED: 1. BOTH VENOUS PRESSURE HIGH ALARMS AND CASES OF CLOTTING DISCOVERED AFTER BLOOD RETURN AT THE END OF DIALYSIS HAVE OCCURRED. 2. THE ESTIMATED BLOOD LOSS OF ABOUT 100 ML IS A ROUGH CLINICAL ASSESSMENT. IN APPROXIMATELY 50% OF CASES WITH GRADE II-III CLOTTING, THE CLINICAL ASSESSMENT INDICATES A BLOOD LOSS OF AROUND 100 ML, WHILE FOR THE OTHER 50%, THE BLOOD LOSS IS ABOUT 50 ML. 3. NO OTHER INJURIES WERE PRESENT. 4. NO SPECIFIC MEDICAL INTERVENTIONS, SUCH AS BLOOD TRANSFUSION, WERE ADMINISTERED. 5. NO SAMPLE IS AVAILABLE.