D
Patient 1
CUSTOMER REPORTED A DISPOSABLE HAD BROKEN INSIDE THEIR CENTRIFUGE MACHINE AND THAT A SMALL AMOUNT OF BLOOD ESCAPED THE CONTAINMENT AREA. THERE WAS NO PATIENT OR USER INJURY. THE CUSTOMER TOOK BIOHAZARD PRECAUTIONS BEFORE OPENING THE MACHINE. THE PROCEDURE WAS COMPLETED USING A SECOND PROCESS DISPOSABLE. THE MACHINE AND DISPOSABLE WERE RETURNED TO HARVEST FOR INVESTIGATION. INVESTIGATION WAS DOCUMENTED AND PICTURES WERE TAKEN. UPON RECEIPT OF THE MACHINE, THERE WAS CLEAR EVIDENCE THAT THE DISPOSABLE WAS IMPROPERLY INSTALLED INTO THE CENTRIFUGE AND RUN WITHOUT IT BEING FULLY SEATED. THE DISPOSABLE WAS STILL WEDGED INTO THE ROTOR AND HAD TO BE PRIED OUT. SCRAPE MARKS ON THE INNER LID GLASS AND DISPOSABLE TOP AS WELL AS PLASTIC PARTICULATE WERE EVIDENT. THE DISPOSABLE WAS DAMAGED FROM CONTACT ON THE LID WHILE SPINNING AND SUBSEQUENTLY RUPTURED WHEN THE G-FORCE WAS TOO GREAT. THE LID BEING SHUT ON THE PROTRUDING DISPOSABLE CAUSED EXCESS UPWARD FORCE ON THE LID CAUSING THE SEAL TO BE COMPROMISED WHEN THE DISPOSABLE HAD FAILED. THE MACHINE WAS CLEANED VERIFIED TO BE WORKING PROPERLY AND RETURNED TO THE CUSTOMER.