Description of Event or Problem · 1
THIS IS JUST NOW BEING REPORTED SINCE WE HAVE RULED OUT OTHER POSSIBLE CAUSES TO THE DEVICE NOT WORKING. IN CHECKING THIS DEVICE WE HAVE FOUND THAT THIS IS THE THIRD TIME IN THE PAST YEAR AND A HALF THAT THIS DEVICE HAS LEAKED WHEN SET UP TO USE FOR A SURGERY. THE FIRST TIME IT OCCURRED WAS 1 1/2 YEARS AGO AND NOT THINKING ANYTHING ABOUT IT, THE DEVICE WAS REPLACED AND DISCARDED. SIX MONTHS LATER THE SAME THING HAPPENED WHEN THE DEVICE WAS ATTACHED TO THE MACHINE IT LEAKED AGAIN. IT WAS AT THAT TIME THE PERFUSIONIST NOTIFIED THE COMPANY, SENT THE DEVICE TO THEM ALONG WITH PICTURES. A REPORT WAS SENT BACK TO THE PERFUSIONIST STATING THE CASE WAS FROM A STRESS SUCH AS DROPPING. THE PERFUSIONIST KNOWING THAT IT WAS NOT DROPPED OR ANYTHING DONE WITH IT WENT ON AND FORGOT ABOUT THE ISSUE. NOW ANOTHER SIX MONTHS HAVE PASSED AND THE SAME PROBLEM OCCURRED. THE PERFUSIONIST WAS SETTING UP FOR A HEART SURGERY, HOOKING UP THE MACHINE AND THE DEVICE LEAKED AGAIN. HE CHANGED OUT THE DEVICE AND SET IT ASIDE. WE HAD BIOMED CHECK OUT OUR EQUIPMENT AND EVERYTHING PASSED. LOOKING AT THE DEVICE THAT WAS SET ASIDE AND SAVED WE COMPARED IT TO THE PICTURES FROM THE PREVIOUS EVENT THAT WAS REPORTED. THERE WAS A MOLDING DEFECT NOTICED. THE FOLLOWING IS WHAT IS REPORTED BY THE PERFUSIONIST. THIS IS THE THIRD TIME WE HAVE SEEN THIS. WHAT WE KNOW: ALL ARE WHAT APPEAR TO BE MOLD DEFECTS OR BENDING/MELTING OF THE OUTLET H2O PORT. ALL ARE FX 25. THE PACKAGING FOR THE MOST RECENT OXYGENATOR SHOWS NO SIGN OF DAMAGE OR TEARING. LOT NUMBERS BEGIN WITH 13. ARE IN THE "W" SERIES (DON'T KNOW IF THE "W" MEANS ANYTHING?). WERE MOLDED WITHIN 6 MONTHS OF EACH OTHER. NOTED THAT THE DEFORMITY OCCURS AT THE 3 O'CLOCK POSITIONS WHEN THE GAS INLET PORT IS AT THE BOTTOM (6 O'CLOCK). THE PERFUSIONIST CHECKED THE STOCK SUPPLY AND DID NOT FIND ANY OTHER DEVICES WITH THIS DEFECT. THE OTHER SIMILARITY IS THAT EACH TIME THIS OCCURS IT HAS BEEN 6 MONTHS FROM THE PREVIOUS EVENT. MFR REPORT #: 9681834-2014-00169.