Description of Event or Problem · 1
AFTER DISCOVERING A FREE-FLOW PROBLEM WITH A SIGMA INFUSION PUMP ON A PT AT MEDICAL CENTER, NURSING ADMINISTRATION AND BIOMEDICAL STAFF BEGAN TO INSPECT EVERY SIGMA 8002 PLUS DUAL CHANNEL INFUSION PUMP IN THE FACILITY FOR CRACKS. THE FREE FLOW REPORTED THAT OCCURRED ON JANUARY 23 WAS NOT THE FIRST FREE-FLOW INCIDENT WITH THE SIGMA DUAL CHANNEL PUMPS, IT WAS THE SECOND. THE FIRST, AS REPORTED TO THE FDA HAD OCCURRED IN AUGUST, 2006. TWO MORE PUMPS HAD BEEN DISCOVERED WITH CRACKS IN THE TUBING CHANNEL, AN AREA WHEREIN STRUCTURAL INTEGRITY IS CRITICAL TO THE SAFE OPERATION OF THESE PUMPS. I TOOK SEVERAL PUMPS APART AND COMPARED THE DESIGN TO THAT OF THE NEARLY-IDENTICAL SINGLE CHANNEL 8000 PLUS MANUFACTURED BY SIGMA. A STARTLING DIFFERENCE WAS NOTED. IN AN AREA OF A PLASTIC CASTING, WHERE STRENGTH IS CRITICAL, A HOLE HAD BEEN DRILLED TO ACCOMODATE AN ASSEMBLY SCREW. THIS HOLE HAS A BRASS THREADED INSERT PRESSED INTO PLACE TO ACCEPT THE ASSEMBLY SCREW. IN MY OPINION, THIS HOLE AND THE PRESSED-IN INSERT GREATLY WEAKENS THE STRUCTURE OF THIS AREA, AN AREA THAT THE PUMPING MECHANISM ACTS AGAINST WHEN DELIVERING THE INFUSED MEDICATION. THIS HOLE IS NOT ON THE SINGLE CHANNEL INFUSION PUMP OF THE SAME MODEL TYPE BY THE SAME MFR. ALL CRACKS THAT HAVE BEEN DISCOVERED ON THESE PUMPS AT THIS FACILITY ALL CENTER AROUND ONE OF THESE TWO HOLES/BRASS INSERTS. THE FRONT OF THE ASSSEMBLY THAT CONTAINS THESE QUESTIONABLE HOLES PROTRUDES FROM THE FRONT OF THE PUMP, OFFERING A SURFACE EASILY IMPACTED WHEN MOVING THE PUMP.