HEMOSAFE

Additional Manufacturer Narrative

MACHINE PRODUCED (SN (B)(4)) IN 07/2009. MORE INFO REQUESTED AT HAEMONETICS SERVICE TEAM: ACTIVITY AND PROCEDURE PERFORMED TO RESTORE THE MACHINE AFTER REPLACING THE CLIP (TECHNICAL REPORT OF SERVICE). MAINTENANCE PROGRAM, IF IN LINE WITH SERVICE HANDBOOK. TRAINING OF THE PERSONNEL OF THE HOSPITAL EMPLOYEE ON THE USER MANUAL INSTRUCTIONS ABOUT WHAT TO DO IN CASE OF MECHANICAL FAILURE (EMERGENCY). MUST BE EVALUATED: THE SW IMPACT IN CASE OF MECHANICAL FAILURE (SOFTWARE ACTIONS IN CASES OF MECHANICAL FRICTION DURING ROTATION). MUST BE EVALUATED: BLOOD BAGS USED BY THE CUSTOMER, DIMENSIONS, MODE, AND WHAT IS STORED WITH BAG. ON ALL THESE POINTS ANGELANTONI LIFE SCIENCE HAS NOT ENOUGH INFO; REQUESTED MORE INFO TO (B)(6) SERVICE TEAM.

Description of Event or Problem

ON (B)(6) 2012, (B)(6) NOTIFIED ANGELANTONI OF AN EVENT THAT OCCURRED ON (B)(6) 2012, WITH AN ANGELANTONI HEMOSAFE REFRIGERATOR RUNNING HAEMONETICS HEMOSAFE BLOODTRACK COURIER SOFTWARE. THE CUSTOMER REPORTED THAT DURING A SURGICAL CASE FOR A RUPTURED ABDOMINAL AORTIC ANEURYSM, A STAFF MEMBER ATTEMPTED TO RETRIEVE ASSIGNED RBC UNITS FROM THE HEMOSAFE AND WAS UNABLE TO DO SO. PER CUSTOMER FEEDBACK, THE ISSUE DESCRIBED POINTED TO A BROKEN PLASTIC CLIP ON THE DISK. THIS CLIP CAUSED AN ERROR, "ERROR LOCKING DOOR" TO BE CONVEYED TO THE USER. PRIOR TO THIS ERROR, SEVERAL UNITS OF RBCS AND PLASMA WERE RETRIEVED FROM THE HEMOSAFE FOR THIS PROCEDURE. THE HOSPITAL STAFF ATTEMPTED TO RESTART THE HEMOSAFE FOUR TIMES WITH THE SAME RESULTS. THE BLOOD SUPPLIER WAS CONTACTED FOR ADDITIONAL UNCROSSMATCHED RBC UNITS TO BE DELIVERED TO THE HOSPITAL, AS THIS HEMOSAFE IS THE ONLY LOCATION THAT BLOOD IS STORED ON SITE AT THE HOSPITAL. THE LAB HAD THE RBC UNITS SENT BY COURIER TO THE HOSPITAL WHICH IS ONE BLOCK AWAY: THE TIME THAT ELAPSED FROM THE REQUEST FOR ADDITIONAL UNITS UNTIL TIME OF DELIVERY TO THE HOSPITAL STAFF WAS APPROXIMATELY 20 MINUTES. THE PT EXPIRED DURING THE SURGERY. A CUSTOMER REPRESENTATIVE WAS ABLE TO REPLACE THE BROKEN CLIP AFTER THE EVENT AND THE MACHINE WAS RETURNED TO PROPER FUNCTION. THERE ARE INSTRUCTIONS IN THE DEVICE MANUAL FOR ACCESSING THE STORED PRODUCTS IF THE DOOR FAILS TO UNLOCK. THE MANUAL STATES, "IN CASE OF EMERGENCY, THE MAIN DOOR TO THE HEMOSAFE CAN BE OPENED. THERE ARE KEYS TO UNLOCK THE MAIN DOOR TO THE HEMOSAFE THAT SHOULD BE STORED NEAR THE HEMOSAFE SO THEY MAY BE ACCESSED QUICKLY IN CASE OF EMERGENCY." THE MANUAL CONTINUES TO PROVIDE DETAILED INSTRUCTIONS ON HOW TO OPEN THE DOOR, UNLOCK THE DISKS AND TURN THEM MANUALLY TO RETRIEVE THE PRODUCT.