Description of Event or Problem · 1
DUE TO A DESIGN FLAW IN THE MEDTRONIC MINIMED QUICK-SERTER MODEL MMT-395, DURING INSERTION OF A QUICK-SET MODEL MMT-393 INSULIN INFUSION SET, THE ADHESIVE PAD AROUND THE CANNULA ADHERED TO THE INSIDE OF THE QUICK-SERTER. IN THE PROCESS OF UN-STICKING THE ADHESIVE PAD FROM THE QUICK-SERTER, (B) (6) DAMAGED THE CANNULA. THIS RESULTED IN SEVERAL PROPERLY-REPORTED "NO DELIVERY" MESSAGES FROM (B) (6) MMT-522 INSULIN INFUSION PUMP OVER THE COURSE OF THE NEXT HOUR, ALONG WITH SEVERAL ATTEMPTS TO RE-START THE FLOW OF INSULIN TO THE PATIENT. AFTER APPROXIMATELY 2 HOURS, (B) (6) REMOVED THE DAMAGED INFUSION SET AND REPLACED IT. THE RESULTING LACK OF INSULIN DELIVERY, AS WELL AS THE UNCERTAINTY AS TO HOW MUCH INSULIN HAD BEEN DELIVERED - DURING THE BLOCKAGE DUE TO THE DESIGN FLAW IN THE QUICK-SERTER, A GREAT DEAL OF INSULIN SPILLED OUT OF THE INFUSION SET, BUT WAS THEREFORE TREATED AS HAVING BEEN DELIVERED BY THE PUMP-, RESULTED IN A SEVERE HYPERGLYCEMIC EPISODE FOR (B) (6), ALONG WITH TWO HYPOGLYCEMIC EVENTS LATER IN THE DAY RESULTING FROM OVER-CORRECTION OF THE HYPERGLYCEMIA. THE DESIGN FLAW IS THAT THE INTERIOR DIMENSION OF THE MMT-395 IS 41 MM, BUT THE ADHESIVE PAD IS 40 MM WIDE. THE LACK OF CLEARANCE BETWEEN THE EDGE OF THE PAD AND THE INSIDE OF THE PLUNGER-TUBE MAKES IT A COMMON FAILURE TO HAVE THE ADHESIVE PAD GET STUCK ONTO THE INSIDE OF THE PLUNGER-TUBE. THE CLEARANCES AND TOLERANCES INVOLVED MAKE IT OBVIOUS THAT THE MMT-395 IS SIMPLY NOT LARGE ENOUGH TO SAFELY INSERT QUICK-SET INFUSION SETS. DATES OF USE: (B) (6) 2004 - (B) (6) 2010. DIAGNOSIS OR REASON FOR USE: TYPE 1 DIABETES.