inforMED
MalfunctionLHC

WARMER, IRRIGATION SOLUTION

Received Jun 20, 2016 · Event occurred Sep 22, 2015

Report 5735174 · MDR key 5735174

Device

Generic name

Warmer, Irrigation Solution

Catalog number

OM-ORS-300

Product problems

  • Fluid/Blood Leak
  • Hole In Material

Patient

1 YR

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

Narrative

Description of Event or Problem

UPON COMPLETION OF AN OPERATING ROOM CASE, THE SCRUB TECH NOTICED A HOLE IN THE DRAPE OF THE STERILE NORMAL SALINE WARMER. A SIGNIFICANT AMOUNT OF NORMAL SALINE WAS FOUND IN THE BOTTOM OF THE WARMER. A DEFECT WAS FOUND IN THE STERILE DRAPE, WHICH WAS REPORTED TO THE CHARGE NURSE AND THE OPERATING ROOM MANAGER.