Description of Event or Problem · 1
PRODUCT IN QUESTION; CURLIN MODEL 6000 AMBULATORY INFUSION PUMP. MFG BY MOOG MEDICAL DEVICES GROUP. IN APRIL 2010, OUR COMPANY PLACED INTO SERVICE (B)(4) OF THE AFFECTED PUMPS. SINCE THAT TIME, APPROX 30% OF THE PUMPS HAVE FAILED WITH AN ERROR CODE "45". WITHOUT WARNING, WHILE INFUSING MEDICATION TO A PT, THE PUMP STOPS AND ERROR 45 IS DISPLAYED. THE MFR INSTRUCTED US TO RESTART THE PUMP. UPON RESTARTING THE PUMP, THE DELIVERY MODE, PROGRAMMED INFUSION PARAMETERS, DATE AND TIME ARE ERASED. WITH THE URGENT NATURE OF THE MEDICATIONS ADMINISTERED, OFTEN ON-CALL PERSONNEL ARE FORCED TO RE-PROGRAM THE PUMP WITH THE PT OR CAREGIVER OVER THE TELEPHONE. THIS ERROR FORCES THE CLINICIAN TO BYPASS PROCEDURES THAT ARE IN PLACE TO DOUBLE CHECK THE INFUSION PROFILE THAT IS PROGRAMMED. WE VIEW THIS AS A SIGNIFICANT RISK FOR A MEDICATION ERROR. ON SEP 28, 2010 MOOG BEGAN A PROCESS OF ADDING A SOFTWARE "PATCH TO ALL OF OUR PUMPS. IMMEDIATELY UPON PLACING THESE DEVICES BACK INTO SERVICE, TWO NEW ERRORS WERE REPORTED IN ESSENTIALLY 100% OF THE PUMPS THAT HAD THE PATCH INSTALLED. AN ERROR CODE "35" WAS OBSERVED THAT WAS ESSENTIALLY THE SAME AS THE ORIGINAL ERROR CODE "45". WHEN RESTARTING THE PUMP AFTER AN ERROR CODE "35" IS RECEIVED THE DATE, TIME, AND PROGRAMMED INFUSION PARAMETERS ARE ERASED. ADDITIONALLY, AFTER THE PATCH, THE PORTION OF THE PROGRAM THAT ALLOWS US TO VIEW THE PUMP HISTORY AND TO RE-SET THE INFUSION PARAMETERS VIA A DATA CABLE WERE DISABLED. ESSENTIALLY THE PATCH TO FIX THE ERROR CODE "45" CREATED TWO ADDITIONAL PROBLEMS. WE HAVE ENGAGED IN MULTIPLE DISCUSSIONS WITH THE MFR TO OBTAIN A RELEVANT "FIX" FOR THE PROBLEM. TO DATE, NO PERMANENT SOLUTION HAS BEEN IDENTIFIED BY THE MFR.