CAREFUSION AREA VENTILATOR

Description of Event or Problem

PT WAS ADMITTED TO THE HOSP ON (B)(6) 2013 FOR POSSIBLE PNEUMONIA. PT WAS LATER DIAGNOSED WITH LESIONS ON THE LUNGS, BILATERAL PNEUMONIA AND (B)(6). ON (B)(6) 2013 THE DOCTOR PREVIOUSLY DECIDED TO PLACE PT ON VENTILATOR TO IMPROVE BREATHING, THE MACHINE KEPT ALARMING INCREASE PEEP OVER SEVERAL HRS. THE TECH CAME IN AND TOLD THE PT'S MOTHER THAT HER SON WAS OVERBREATHING THE MACHINE AND CHANGED THE SETTINGS. THE NEXT DAY OR SO THE DOCTOR TOLD THE PT'S MOM THAT THE PT IS LOOKING BETTER AND MAYBE TAKEN OFF THE VENTILATOR AND CHANGED TO A DIFFERENT ROOM. THE DOCTOR ALSO TOLD MOM EVEN THOUGH PT IS GETTING BETTER HE STILL WILL NOT BE RELEASED FOR ABOUT 4-7 DAYS. THE DAY THE PT WAS MOVED TO A DIFFERENT ROOM, THE PT'S MOTHER WALKS INTO THE ROOM AT THE SAME TIME THE DISPOSABLE EXPIRATORY HOSE BROKE OFF THE VENTILATOR AND THE NURSE BEGAN MANUALLY VENTILATING THE PT FOR APPROX 7 MINUTES. PT WAS COUGHING UP BLOOD AND O2 25-30%. WHEN PT WAS PLACED BACK ON THE VENTILATOR O2 WAS 80% ON 100% OXYGEN. THIRTEEN HOURS AFTER PT PLACED BACK ON VENTILATOR HE DIED. PT'S MOM LOOKED UP THE VENTILATOR FROM CAREFUSION ON-LINE AND SAID THAT IT HAS BEEN RECALLED, SHE WAS CONCERNED THAT THE HOSP ALREADY KNEW THE DEVICE WAS RECALLED AND WAS USING IT ANYWAY. ALSO MOTHER STATES THAT THE VIASYS WAS RECALLED AS WELL.

Description of Event or Problem

ADD'L INFO RECEIVED FROM REPORTER ON 01/29/2016. REPORTER WOULD LIKE TO INFORM THE FDA THAT BY THE TIME THIS DEVICE WAS BEING USED ON HER SON. THERE HAD ALREADY BEEN A RECALL ON IT BECAUSE THE Y-PIECE WAS CRACKING. RECENTLY IT WAS UPGRADED TO A GLOBAL RECALL. REPORTER FURTHER SAYS WHEN SHE LEARNT OF THIS, SHE CALLED CAREFUSION, BUT WHEN THE SERIAL NUMBER WAS MENTIONED, THE PHONE COMMUNICATION WAS IMMEDIATELY DISCONNECTED. THIS HAS BEEN THE CASE FOR THE PAST COUPLE OF TIMES SHE HAS CALLED CAREFUSION.

Description of Event or Problem

ADD'L INFO RECEIVED ON 02/22/2016: I MADE A COMPLAINT BACK IN 2013, AND THEY SAID THAT MY REPORT WOULD BE UPDATED IN SEVEN WEEKS, IT'S BEEN THREE YEARS AND STILL NO SUCH THING. UNFORTUNATELY THE HOSPITAL NEVER CALLED AND REPORTED THE ACCIDENT, EITHER I DIDN'T KNOW IT WAS MY RESPONSIBILITY TO DO SO BUT I DID I HAVE EMAILS FROM ONE AND ASSOCIATES FROM THE FDA BACK IN 2013.