Description of Event or Problem · 1
HOSPIRA ISSUED AN "URGENT DEVICE FIELD CORRECTION" NOTICE DATED 02/27/2013 TO THEIR CUSTOMERS REGARDING A "DOOR TAMPERING" ISSUE WITH THEIR LIFECARE PCA INFUSION PUMPS. IT STATED THAT IN Q4 2013, HOSPIRA WOULD BEGIN THE PROCESS TO CORRECT ALL DEVICES IN THE FIELD IMPACTED BY THIS ISSUE BY INSTALLING A REDESIGNED DOOR. AS OF TODAY, NOTHING HAS BEEN DONE. IN TALKING WITH HOSPIRA THIS WEEK, I WAS TOLD THAT THEY STILL HAD NO NEWS ABOUT THE "NEW" DOORS, BUT MAYBE BY THE END OF THIS YEAR 2014. IT HAS BEEN OVER A YEAR AND A HALF AND I HAVE ABOUT HALF OF MY UNITS OUT OF SERVICE WITH BROKEN DOORS WAITING ON THE NEW DOORS. I WAS TOLD THAT I COULD BUY REPLACEMENT DOOR KITS AT AN INFLATED PRICE BUT NOT THE INDIVIDUAL PARTS I NEED AS I COULD BEFORE THE RECALL, BUT THESE DOORS ARE THE SAME AS THE DOORS THAT ARE BEING REDESIGNED AND REPLACED UNDER THE RECALL. AS THIS PROCESS CONTINUES TO DRAG ON, I CONTINUE TO HAVE DOORS THAT BREAK AND CANNOT BE SECURED PROPERLY INCREASING THE CHANCE OF "TAMPERING" WITH THE NARCOTICS BEING ADMINISTERED BY THESE UNITS. WE HAVE BEEN FORTUNATE ENOUGH TO KEEP ENOUGH UNITS GOING SO FAR THAT IT HAS NOT IMPACTED PATIENT CARE, BUT I AM AFRAID THAT THE DAY WILL COME IN THE NEAR FUTURE THAT WE WILL NOT BE SO FORTUNATE. WE HAVE BEEN TOLD THAT THEY (HOSPIRA) ARE HAVING A DIFFICULT TIME SECURING A VENDOR TO MANUFACTURE THE REPLACEMENT DOORS. I FIND THAT EXPLANATION VERY DIFFICULT TO BELIEVE SINCE IT HAS BEEN BETTER THAN 18 MONTHS SINCE THE NOTIFICATION WAS SENT OUT. NEEDLESS TO SAY, MY HOSPITAL AND I ARE VERY DISPLEASED ABOUT THE COMPANY'S RESPONSE TO THIS ISSUE. OUR QUESTIONS AND COMPLAINTS GET "LIP-SERVICE", BUT NO ACTION AND THIS IS THE REASON FOR MY MEDWATCH REPORT.