MalfunctionNKP
MANIFOLD
Received Oct 10, 2012 · Event occurred Sep 24, 2012
Report MW5027240 · MDR key 2792480
Device
Product problems
- Air Leak
- Manufacturing, Packaging or Shipping Problem
Patient
72 YR
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
MANIFOLD FOR CONTRAST AND SALINE INJECTION HAS A SPIKE THAT CONNECTS TO SALINE BAG, THIS SPIKE CONTAINED ANOTHER METAL SPIKE WHICH SHOULD NOT HAVE BEEN THERE. THIS CAUSED A HIGH AMOUNT OF BUBBLES IN CHAMBER THAT COULD HAVE BEEN INJECTED INTO THE PT'S CORONARIES. ABBOTT REPS CALLED AND WILL REPLACE PACKS WITH CORRECT MANIFOLDS.