Description of Event or Problem · 0
CLINIC STATED THAT THEY HAVE EXPERIENCED AN INCREASE IN CLOTTED DIALYZERS SINCE SWITCHING FROM OPTIFLUX DIALYZERS TO ELISIO DIALYZERS. TREATMENTS ARE INTERRUPTED, AND MOST ARE UNABLE TO RETURN THE PATIENT'S BLOOD.THE CLOTTING IS NOT PATIENT, DIALYZER SIZE, OR USER SPECIFIC. 3 TOTAL INCIDENTS: (B)(6) 2021 - 1 INCIDENT (PATIENT REQUIRED BLOOD TRANSFUSION ON (B)(6) 2021) (B)(6) 2021 - 1 INCIDENT (B)(6) 2021 - 1 INCIDENT CLINICAL SPECIALIST CONTACTED THE FACILITY AND OFFERED IN-PERSON PRODUCT TRAINING FOR MAY 3, 4, AND 5TH 2021. CLINIC WAS ADVISED TO FOLLOW IFU FOR PROPER PRIMING INSTRUCTIONS, BECAUSE THE STAFF WAS FOLLOWING CLINIC PROTOCOLS AND NOT THE PRODUCT IFU. AFTER OUR CLINICAL SPECIALIST VISITED THE CLINIC AND OBSERVED THE STAFF DURING PRIMING AND RECIRCULATING PROCESS, IT WAS IDENTIFIED THAT THE CLINIC WAS RECIRCULATING WITH 100ML INSTEAD OF 200ML AS INSTRUCTED IN THE IFU. ARTERIAL CHAMBERS WERE ALSO OBSERVED NOT BE BE 75% FULL IN SOME CASES. DURING HER VISIT TO THE CLINIC, THE NURSE MANAGER ADVISED THAT A PATIENT REQUIRED A BLOOD TRANSFUSION 2 DAYS AFTER TREATMENT WAS INTERRUPTED AND THE PATIENT'S BLOOD COULD NOT BE RETURNED DUE TO THE CLOTTED DIALYZER. ALL DATA WAS DOCUMENTED AND AN EMAIL WITH HER FINDINGS WAS SENT TO THE NURSE MANAGER, PROVIDING INSTRUCTIONS FOR PROPER PRIMING, RECIRC, AND LEVELS OF BLOODLINE CHAMBERS. INITIAL DATE OF OCCURENCE IS UNKNOWN. CLINIC STATED THE FIRST INCIDENT OCCURRED SOMETIME IN (B)(6). DIALZYER SIZE WAS LATER RECEIVED 04/28/2021.