MEDRAD SVTS TRANSFER SET
Received Apr 3, 2014 · Event occurred Mar 28, 2014
Report 3743821 · MDR key 3743821
Device
Generic name
Tubing, Fluid Delivery
Manufacturer
Bayer Medical, Inc.Model number
*Catalog number
*
Lot number
106237
Product problems
- Filling Problem
- Defective Component
Patient
76 YR
- No Code Available
Narrative
Description of Event or Problem
I WAS ATTEMPTING TO LOAD THE MEDRAD INJECTOR FOR A CT EXAM. THE INJECTOR IS A DUAL INJECTOR ONE SYRINGE IS SALINE THE OTHER SYRINGE IS CONTRAST. WE USE SWABBABLE VALVE TRANSFER SETS TO LOAD BOTH SYRINGES FROM OUR SALINE BAG AND CONTRAST BOTTLE WHICH ARE HUNG ABOVE THE SYRINGES. THE SALINE SIDE OF THE INJECTOR FILLED WITHOUT ANY ISSUES BUT I COULD NOT FILL THE CONTRAST SYRINGE. I CHANGED THE TRANSFER SET SEVERAL TIMES, TURNED THE INJECTOR OFF AND ON TO SEE IF I COULD CLEAR THE PROBLEM. I THEN CALLED THE CT SUPERVISOR, TO SEE IF SHE COULD IDENTIFY THE PROBLEM. AT THAT POINT WE CALLED BIOMED. BIOMED CHECKED THE INJECTOR AND THEN CALLED MEDRAD. MEDRAD STATED IT HAD TO BE THE TUBING NOT THE INJECTOR. BIOMED STAFF USED A DIFFERENT LOT NUMBER TUBING AND THE CONTRAST SIDE OF THE INJECTOR WAS ABLE TO BE LOADED. I NOTIFIED MATERIALS MANAGEMENT AND THEY BROUGHT US A NEW SUPPLY OF TRANSFER SETS AND PULLED THE LOT #106237 WHICH WERE DEFECTIVE. I THEN NOTIFIED THE CT DEPT IN AN AFFILIATE IN CASE THEY HAD ANY OF THE SAME LOT NUMBER. THE PATIENT THAT WAS WAITING FOR EXAM CHOSE TO RESCHEDULE HIS APPOINTMENT. HE WAS OFFERED THE CHOICE OF GOING TO THE AFFILIATE CAMPUS OR WAITING FOR INJECTOR PROBLEM TO BE FIXED.