GAMMAMED PLUS

Description of Event or Problem

SUPPLEMENTAL INFO: THE INITIAL BIOHAZARD CONTAMINATION OCCURRED ON (B)(6) 2009 AND WAS A RESULT OF CUSTOMER PROCEDURE WHICH WAS RECOGNIZED AT THE TIME OF OCCURRENCE. DURING THE PROCEDURAL SET UP, THE CUSTOMER HAD REMOVED A PART OF THE MIAMI APPLICATOR THAT IS DESIGNED TO PREVENT LEAKING INTO THE AFTERLOADER. THE CUSTOMER WAS AWARE OF THE CONTAMINATION IMMEDIATELY AFTER THE PROCEDURE AND CONTACTED VARIAN SERVICE. THE CONTENTION OF REMAINING CONTAMINATION WAS IN RELATION OF THE PROCESS USED TO REMOVE THE CONTAMINATED SOURCE. CUSTOMER SITE PROVIDED THE FOLLOWING STATEMENT: "REGARDING THE CONTAMINATED SOURCE GUIDE TUBE. INFECTION CONTROL INVESTIGATED THIS ISSUE AND CONCLUDED THAT NO PT OR STAFF MEMBERS WERE INJURED AS A RESULT OF THIS TRANSFER TUBE."

Additional Manufacturer Narrative

CONCLUSION: THE EVENT WAS RELATED TO THE POSSIBLE ACTIONS OF ONE FSE PERSONNEL DURING THE (B)(4) SERVICE VISIT. IT COULD NOT BE POSITIVELY KNOWN IF THE CROSS CONTAMINATION ACTUALLY DID OCCUR, SO THE F/U ACTIONS BY A DIFFERENT FSE ON (B)(4) PROCEEDED AS THOUGH IT WAS A CONTAMINATED MACHINE ONCE THE CUSTOMER HAD INDICATED THEY THOUGHT A CONTAMINATED TRANSFER GUIDE TUBE HAD CONTINUED TO BE USED FROM (B)(6). VARIAN SERVICE PERSONNEL WILL BE RE-TRAINED ON HANDLING BIOHAZARD CONTAMINATION AS F/U TO THIS COMPLAINT.