TISSUE-TEK VIP 6

Description of Event or Problem

SAKURA WAS NOTIFIED ON (B)(6) 2013 OF AN INCIDENT WHICH OCCURRED ON (B)(6) 2012. SITE STATED THAT THEIR VIP-6 INSTRUMENT WAS HAVING ISSUES WITH THE PUMP DUE TO INTERNAL CLOGGING SINCE (B)(6) 2012. ON (B)(6) 2012, THE SITE HAD AN INCIDENT WHERE THE TISSUES WERE BEING POORLY PROCESSED. THREE CORE BIOPSY CASES WERE UNREADABLE AND AFTER REPROCESSING THE PATHOLOGIST STILL COULD NOT MAKE A DIAGNOSIS. THIS RESULTED IN THE PTS HAVING TO GO BACK FOR RE-BIOPSY.

Additional Manufacturer Narrative

SFA WAS NOTIFIED OF THIS INCIDENT ON (B)(6) 2013. SFA'S INVESTIGATION REVEALED THAT THE PREVENTIVE MAINTENANCE SVC WAS PERFORMED BY A NON-SAKURA TRAINED SVC PROVIDER, (B)(4), IN (B)(4) 2012. THE SITE HAS BEEN USING RECYCLED XYLENE SUBSTITUTE CONTINUOUSLY FOR THE CLEAN CYCLE. THE USE OF RECYCLED XYLENE SUBSTITUTE FOR CLEANING CAN ACCELERATE A BUILDUP OF SALTS/PRECIPITATES IN THE VIP, THEREFORE, REQUIRES MORE FREQUENT CLEANING AND MAINTENANCE. FURTHER, THE VIP6 OPERATING MANUAL (P/N 0002604-01) , REV. E, CLEARLY STATES IN PG 6.1 AND 6.2 THAT "IF A XYLENE SUBSTITUTE IS USED FOR THE CLEAN CYCLE PROCESS, IT MAY REQUIRE MORE FREQUENT REPLACEMENT," "IF MANUALLY REPLACING REAGENTS, EMPTY EACH BOTTLE, RINSE WITH COMPATIBLE REAGENT AND REFILL WITH THE APPROPRIATE VOLUME OF FRESH REAGENT." ON (B)(6) 2013, SITE EXPLAINED THAT SINCE THIS INCIDENT OCCURRED, THEY STOPPED USING THE RECYCLED XYLENE SUBSTITUTE AND HAVE BEEN USING ONLY FRESH XYLENE SUBSTITUTE FOR CLEANING. THE INSTRUMENT HAS BEEN RUNNING SMOOTHLY SINCE THEN WITH MINIMAL ERRORS WHICH THEY COULD RESOLVE THEMSELVES.