Description of Event or Problem · 1
HOSPITAL SWITCHED OVER TO NEW NEEDLELESS SYSTEM, MICROCLAVE BY ICU MEDICAL, INC. STAFF REPORTED THAT THEY WERE UNABLE TO UTILIZE THE MICROCLAVE DEVICE TO DRAW BLOOD OR FLUSH CENTRAL LINES AND ARTERIAL LINES. STAFF ALSO UNABLE TO UTILIZE 4-WAY STOPCOCKS (HI-FLO BY SMITHS MEDICAL)DURING RESUSCITATIONS OR HIGH VOLUME FLUID PUSHES. STAFF UNABLE TO UTILIZE PUSH-PULL TECHNIQUE. STAFF WERE FINDING THAT THEY HAD TO REMOVE THE MICROCLAVE CAP AND DIRECTLY ACCESS THE LUER CONNECTOR TO THE SYRINGE, WHICH OPENED THE SYSTEM, CREATING A PORTAL FOR POTENTIAL INFECTION (AND WHICH THE MICROCLAVE SYSTEM WAS SUPPOSED TO PREVENT). COMPANY SALES REPRESENTATIVE WAS NOTIFIED AND HE STATED THAT THE COMPANY HAD RECENTLY CHANGED THE PRODUCT, AND HE WOULD HAVE 200 NEW COMPATIBLE CAPS SENT OVERNIGHT WHICH WOULD SOLVE THE PROBLEM. IN THE MEANTIME, HE INSTRUCTED THE STAFF TO USE A 3 WAY STOPCOCK WHICH HAS A SMALLER INTERNAL DIAMETER, AND CREATE A "T" CONNECTION USING ANOTHER CLAVE PRODUCT, A 6" SMALLBORE EXTENSION SET WITH REMOVABLE MICROCLAVE, CLAMP AND LUER LOCK. AS IT TURNED OUT, THE REPRESENTATIVE WAS UNABLE TO OVERNIGHT THE NEW PRODUCT, SO THERE WILL BE APPROXIMATELY A 3-4 WEEK TIME BEFORE THE "NEW" VERSION OF THE MICROCLAVE CAN BE SENT.ANALYSIS OF THE ISSUES REVEALED THAT PART OF THE PROBLEM MIGHT BE THAT THE HI-FLO 4 WAY STOPCOCK HAS A LARGER INTERNAL DIAMETER THAN THE MICROCLAVE CAPS, PROBABLY CREATING A SITUATION WHERE FLUID IS MOVING AT A HIGHER VOLUME THROUGH THE SYRINGE/STOPCOCK SET-UP, THEN BECOMES MORE DIFFICULT TO PUSH OR ASPIRATE VIA THE SMALLER DIAMETER MICROCLAVE CAP. THIS IS A HOSPITAL-WIDE ISSUE (PEDIATRIC HOSPITAL).STAFF HAVE QUESTIONED WHETHER THE COMPANY TRIED TO SELL OFF A LARGE BATCH OF THEIR "OLD MODEL" MICROCLAVE CAPS KNOWING THAT THEY DID NOT WORK AS WELL AS THE NEWER CAPS IN PRODUCTION.STAFF ALSO REPORTED THAT THE COMPANY REPRESENTATIVE INSTRUCTED THEM TO CHANGE THE MICROCLAVE CAPS DAILY AS THE "SPLIT SEPTUM" IN THE CLAVE CAP CAN WEAR OUT WITH REPEATED ACCESS. IT IS UNCLEAR WHETHER THIS WAS BROUGHT UP DURING THE VALUE ANALYSIS INVESTIGATION OF THE PRODUCT.STAFF CONTINUE TO HAVE DIFFICULTY WITH THE NEW MICROCLAVE PRODUCT AND HAVE COMMUNICATED THE USE OF THE 3 WAY STOPCOCK AND CLAVE EXTENSION TO IMPROVE FLUID FLOW.OF NOTE, THE OLDER CLAVE CAP APPARENTLY HAS THE "DYNAMIC SEAL" THAT SITS UP A TINY BIT (~1 MM) HIGHER THAN THE BLUE LUER CAP, WHILE THE NEWER PRODUCT SITS FLUSH. ====================== HEALTH PROFESSIONAL'S IMPRESSION======================MAY BE RELATED TO THE PHYSICS BEHIND TRYING TO MOVE FLUIDS FROM A LARGER DIAMETER PRODUCT THROUGH A SMALLER DIAMETER PRODUCT. HOWEVER, THE SALES REPRESENTATIVE SHOULD HAVE BEEN ABLE TO ASSESS THE ISSUE. IT COULD ALSO BE A PROBLEM WITH THE DESIGN OF THE OLDER PRODUCT.======================MANUFACTURER RESPONSE FOR NEEDLE FREE CLOSED SYSTEM DEVICE FOR IV ACCESS, MICROCLAVE NEUTRAL DISPLACEMENT CONNECTOR======================SALES REPRESENTATIVE INDICATED THAT 200 OF NEW PRODUCT WOULD BE OVERNIGHTED TO THE HOSPITAL, BUT THEN WAS UNABLE TO DO THAT. LAST INDICATION WAS THAT IT WOULD TAKE 3-4 WEEKS FOR NEW PRODUCT LINE.