inforMED
MalfunctionLHC

ORS FLUID WARMING AND SLUSH DRAPE

Received Mar 17, 2016 · Event occurred Mar 26, 2015

Report 5506871 · MDR key 5506871

Device

Generic name

Warmer, Irrigation Solution

Lot number

D143161

Product problems

  • Hole In Material

Patient

59 YR

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

Narrative

Description of Event or Problem

THE SCRUB TECH NOTICED DURING SURGERY THAT THERE WAS SOME WATER UNDER THE FLUID WARMER DRAPE AND IN THE FLUID WARMER PAN. THE FLUID WARMER WAS IMMEDIATELY REMOVED FROM THE STERILE FIELD. THE DRAPE WAS INSPECTED A COUPLE OF TIMES UNTIL A TINY HOLE WAS FOUND IN THE WARMER DRAPE. A NEW STERILE GRADUATE AND IRRIGATION BULB WAS GIVEN TO THE SCRUB TECH AND FILLED WITH A NEW WARM N.S. IT WAS DETERMINED THAT THERE WERE 8 LAPS MOISTENED WITH THE N.S. THAT WAS IN THE FLUID WARMER. THE SURGEONS WERE NOTIFIED AFTER THE HOLE WAS FOUND.