inforMED
MalfunctionLHC

WARMER, IRRIGATION SOLUTION

Received Apr 11, 2019 · Event occurred Apr 2, 2019

Report 8043817-2019-40017 · MDR key 8506057

Device

Generic name

Fluid Warming And Slush Drape

Model number

ORS-321

Lot number

D183499

Product problems

  • Material Puncture/Hole
  • Material Puncture/Hole

Patient

Not reported

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

IT WAS REPORTED THAT A HOLE WAS OBSERVED IN THE WARMER SIDE OF DRAPE AND IT WAS MORE THAN CONDENSATION. IT WAS SIGNIFICANT AMOUNT OF FLUID. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.