Description of Event or Problem · 1
BAXTER PCA PUMP- I PUMP. WE RECEIVED INFORMATION 3-13-06 FROM BAXTER VIA FAX WITH A DATED 12/21/2005 URGENT DEVICE CORRECTION NOTICE. OUR CENTRAL SUPPLY MANAGER CONTACTED THE REPRESENTATIVE FROM BAXTER. THE BAXTER COMPANY THEN CHANGED OUR FACILITY REP, AND THERE WAS A GAP IN SERVICE. THE 12/21/2005 NOTICE STATED THAT BAXTER HEALTHCARE CORP WAS SENDING THIS COMMUNICATION TO PROVIDE IMPORTANT INFO RELATED TO POTENTIAL ELECTRICAL SHORT IN THE PCA CIRCUIT, SIMULATING REPEATED PRESSING OF THE PCA BUTTON. THE DOCUMENT STATES THAT THE UNREQUESTED BOLUS DOSES WILL NOT EXCEED THE PROGRAMMED PRESCRIBED LIMITS. THE DOCUMENT ALSO STATED THAT THERE WAS POSSIBILITY FOR FLUID INGRESS INTO THE PUMP, OR THE PCA BUTTON. IN 2005, HOSPITAL AND MEDICAL CENTER PURCHASED NEW PCA PUMPS FROM BAXTER, THE I PUMP. THIS PUMP HAD AN UPDATED " UPSTREAM OCCLUSION" ALARM, TO ASSURE THAT PATIENTS WOULD GET THEIR MEDICATION AS PRESCRIBED, AND IF THERE WAS AN OCCLUSION, THERE WOULD BE AN ALERT FOR THE CARE PROVIDER. THE BAXTER COMPANY DID NOT COMMUNICATE BACK WITH HOSPITAL TO DETERMINE A COURSE OF ACTION TO CORRECT THE DECEMBER 21, 2005 DEVICE CORRECTION TITLED "DELIVERY OF UNREQUESTED PCA DOSES DUE TO DAMAGED PCA CORDS AND FLUID INGRESS." THE NEXT COMMUNICATION WE HAVE FROM BAXTER IS 3/14/07 - SUBJECT- FOLLOW UP PREVIOUS I PUMP PAIN MANAGEMENT SYSTEM FIELD ACTIONS. THE COMPANY GOES ON TO SAY THAT THEY ARE INFORMING US THAT THEY ARE NOW READY TO BEGIN DEPLOYMENT OF UPGRADES TO THE IPUMP. THE UPGRADES THAT WILL BE ADDED TO THE PUMP, PROVIDED WE SEND THE PUMPS FOR SERVICE, WHICH WILL CAUSE OUR FACILITY TO HAVE BOTH UPGRADED AND NON UPGRADED PUMPS. THE UPGRADES NEEDED INCLUDE: 1- UPSTREAM OCCLUSION START UP TEST, 2- " SET NOT PRIMED" ALARM, 3- ELECTRO STATIC DISCHARGE - ESD PROTECTION, 4- KEY ONLY SECURITY MODE, 5- HISTORY PRINT OUT ERROR, 6 - FAST ADVANCE HISTORY FEATURE, 7- USE PREVIOUS RX? 8- FLUID VOLUME IN " USE INTIAL RX?" WHEN PRIMING THROUGH THE PUMP, 9- THE " SELECT ACTION" DEFAULT IS "FLUID VOLUME" INSTEAD OF "PRIME", 10 - SYSTEM ERROR 32 AND SYSTEM ERROR 33 HARDWARE CHANGES, 11- PCA CORD & AND BUTTON HAVE BEEN REDESIGNED, 12- OPERATOR MANUAL CHANGES. THE ACTIONS BY BAXTER ARE UNACCEPTABLE BECAUSE: 1- WE DID NOT RECEIVE NOTIFICATION FROM DEC 21, 2005 UNTIL MARCH 14, 2007 AS TO WHAT CO PLANS TO DO TO RECTIFY THE DEVICE DEFECTS LISTED ABOVE. THIS IS A POTENTIAL PATIENT SAFETY ISSUE. PATIENT LISTED ABOVE HAD AN ADVERSE EVENT, AND THERE IS A POSSIBILITY VIA INITIAL AUTOPSY REPORT THAT SHE HAD HIGH LEVELS OF NARCOTIC. 2- # 5 ABOVE- HISTORY PRINT OUT ERROR- WE HAVE BEEN UNABLE TO PRINT OUT HISTORY FROM A PUMP WE TOOK OUT OF SERVICE AFTER THE EVENT DESCRIBED WITH THE PATIENT. AFTER LOCATING A COMPATIBLE PRINTER, AND ASSOCIATED CABLES - BAXTER COULD NOT PROVIDE A PRINTER FOR US/THEY DID NOT HAVE A PRINTER COMPATIBLE, FORCING US TO PURCHASE THE PRINTER FROM ANOTHER VENDOR, AND ADAPT A SYSTEM OF CABLES AND ADAPTORS TO BE ABLE TO DETERMINE THAT INDEED THERE WAS " HISTORY NOT AVAILABLE" PROMPT FROM THIS PUMP. 3- BAXTER HAS NOT BEEN RESPONSIVE, NOR PRO ACTIVE IN ASSISTING OUR HOSPITAL WITH THIS DEVICE CORRECTION- THE PUMPS WERE FAULTY, AND WE ARE INCONVEINENCED DUE TO THIS BAXTER PROBLEM. WE HAVE ALSO RECEIVED RECENT DEVICE CORRECTION NOTIFICATIONS FOR THE BAXTER COLLEGUE IV PUMP, AND WE HAD PURCHASED THESE FOR OUR ICU/CCU SPECIFICALLY. THESE PUMPS WILL ALSO HAVE TO BE RETURNED TO BAXTER OR DEVICE CORRECTION.