HEMODIALYSIS SYSTEM FOR HOME USE

Description of Event or Problem

THE BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO (B)(6) THAT THE COMBI SET BLOODLINES WERE CONNECTED TO THE PATIENT'S CATHETER (NOT A (B)(6) PRODUCT) AND CAME APART DURING HEMODIALYSIS (HD) TREATMENT RESULTING IN BLOOD LOSS. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP WITH THE CLINIC MANAGER (CM). THE BLOOD LEAK OCCURRED APPROXIMATELY 2HR AND 31 MIN AFTER TREATMENT INITIATION. THE VENOUS LINE DISCONNECTED FROM THE CENTRAL VENOUS CATHETER (CVC) LIMB. THE DISCONNECTION WAS LOOSE AND NOT COMPLETELY DETACHED. THE ISSUE WAS IDENTIFIED BY CLINIC STAFF. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS 150 ML. THERE WAS NO SERIOUS INJURY OR REQUIRED MEDICAL ATTENTION REGARDING THIS ISSUE. THE PATIENT COMPLETED TREATMENT ON THE SAME MACHINE WITH NEW SUPPLIES. THE SAMPLE WAS DISCARDED AND IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA OF A FORM OF A NOTIFICATION PER 803.22 (B)(2).