COMBISET SMARTECH BLOODLINE (NO HEPARIN)

Additional Manufacturer Narrative

PLANT INVESTIGATION: THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

Description of Event or Problem

ON 23/DEC/2025, FRESENIUS BECAME AWARE THIS PATIENT WITH END STAGE RENAL DISEASE (ESRD) ON HEMODIALYSIS (HD) UTILIZING A FRESENIUS COMBISET SMARTECH BLOODLINE FOR RENAL REPLACEMENT THERAPY (RRT) EXPERIENCED A BLOOD LEAK WHILE UNDERGOING HD THERAPY ON (B)(6) 2025. IT WAS REPORTED THE PATIENT¿S COMBISET SMARTECH BLOODLINE APPEARED TO BE LEAKING AROUND THE ¿PIGTAIL,¿ TRANSDUCER TUBING, AND VENOUS CHAMBER. AS A RESULT, THE PATIENT¿S TREATMENT WAS DISCONTINUED, A STAT HEMOGLOBIN (HGB) WAS COLLECTED, AND A NEW TREATMENT SET-UP WAS UTILIZED. FOLLOW-UP WITH THE PATIENT¿S NURSE MANAGER (NM) REVEALED HALFWAY THROUGH THE TREATMENT, THE CASSETTE STARTED LEAKING FROM 3 DIFFERENT PORTS AS PREVIOUSLY STATED. THE NM STATED ALL THE APPROPRIATE LINES WERE CLAMPED, AND NO DEFECT WAS NOTED INTERNALLY OR EXTERNALLY. THE PATIENT¿S TREATMENT WAS IMMEDIATELY STOPPED, AND THE PATIENT¿S BLOOD WAS NOT RETURNED DUE TO THE UNKNOWN SOURCE OF THE LEAK. THE PATIENT WAS GIVEN AN INCREASED MIRCERA DOSE ON THE DAY OF THE EVENT FOR TWO REASONS: 1. THE PATIENT¿S HGB WAS ALREADY TRENDING DOWN, AND AN INCREASED DOSE WAS SCHEDULED REGARDLESS. 2. THE NEW LAB PROCESSING BLOOD SAMPLES HAS BEEN LATE PROVIDING RESULTS, AND THE NEPHROLOGIST WANTED THE INCREASED MIRCERA DOSE TO BE GIVEN BEFORE THE PATIENT¿S TREATMENT WAS COMPLETED. THEREFORE, THE NEPHROLOGIST ORDERED THE CLINIC TO ADMINISTER DOUBLE THE PATIENT¿S STANDARD DOSE. THE HBG RESULT DID RETURN PRIOR TO THE END OF TREATMENT, HOWEVER THE MIRCERA HAD ALREADY BEEN ADMINISTERED. THE PATIENT¿S HGB PRETREATMENT WAS 12.5 G/DL, AND FOLLOWING THE BLOOD LEAK WAS 11.0 G/DL. THE PATIENT¿S TREATMENT WAS RESTARTED ON THE SAME MACHINE WITH NEW SUPPLIES AND WAS COMPLETED WITHOUT FURTHER INCIDENT. THE NM STATED THE CASSETTE WAS PROPERLY SEATED IN THE HOUSING, AND SHE HAS NO IDEA WHY THE LEAK OCCURRED. THE PATIENT DID NOT REQUIRE MEDICAL ATTENTION DUE TO THE ADVERSE EVENT, AND THE ESTIMATED BLOOD LOSS WAS 250 ML.