THE SAMPLE IS NOT AVAILABLE FOR EVALUATION AS IT WAS DISCARDED AT THE FACILITY. A DEFINITIVE CONCLUSION REGARDING THE COMPLAINT INCIDENT CANNOT BE REACHED WITHOUT A PHYSICAL EXAMINATION OF THE COMPLAINT SAMPLE. DURING THE LOT HISTORY REVIEW IT WAS NOTED THERE ARE NO OTHER REPORTED COMPLAINTS AGAINST THE LOT. THE PRODUCTION RECORD WAS REVIEWED AND THERE WAS ONE APPROVED TEMPORARY DN NOTED ON THE LOT. IT IS UNRELATED TO THE REPORTED COMPLAINT EVENT. THERE WAS NO INDICATION OF PRODUCT NON-ACCEPTANCE OR DEVIATION IN THE MANUFACTURING PROCESS POTENTIALLY RELATED TO THE COMPLAINT. THIS INCLUDES NON-CONFORMANCES, REWORK, LABELING, PROCESS CONTROLS AND ANY OTHER OCCURRENCE IN PRODUCTION. THE REPORTED LOT NUMBER PASSED PYROGEN TESTING, WAS WITHIN STERILIZATION DOSAGE PARAMETERS AND PASSED ALL RELEASE CRITERIA.
D
Patient 1
BIOMED FROM A USER FACILITY REPORTED OF A MAJOR BLOOD LEAK ACROSS THE DIALYZER. DURING FOLLOW UP THE NURSE TEAM LEAD REPORTED THE PATIENT WAS EARLY IN TREATMENT AND SALINE WAS JUST FINISHED WHEN THE NURSE AT THE MACHINE NOTICED A BLOOD LEAK FROM THE TOP OF THE DIALYZER (INTERNAL) THE LEAK WAS APPARENT IN THE DIALYSATE FROM THE TOP END. THERE MAY HAVE BEEN AN END CAP ISSUE AS THE LEAK ORIGINATED NEAR THERE. THEY DID NOT USE THE BLOOD TEST STRIPS AS THE BLOOD WAS READILY VISIBLE. THE MACHINE DID ALARM AS EXPECTED. THE PATIENT LOST APPROXIMATELY 100 TO 150 ML OF BLOOD BEFORE TREATMENT WAS STOPPED. THE PATIENT WAS MOVED TO ANOTHER MACHINE WITHOUT INCIDENT. NO SERIOUS ADVERSE EVENT WAS REPORTED. THE DIALYZER IS BELIEVED TO HAVE BEEN DISCARDED