inforMED
MalfunctionLHC

WARMER, IRRIGATION SOLUTION

Received Jun 20, 2016 · Event occurred Oct 7, 2015

Report 5735170 · MDR key 5735170

Device

Generic name

Warmer, Irrigation Solution

Catalog number

ORS-320

Lot number

D143431

Product problems

  • Fluid/Blood Leak

Patient

0 YR

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

Narrative

Description of Event or Problem

WENT THROUGH ENTIRE CASE AND NOTICED AFTER THE PATIENT LEFT THE ROOM THAT THERE WAS ABOUT 1 CM OF IRRIGATION UNDERNEATH THE STERILE SLUSH DRAPE. CHECKED FOR LEAKS, BUT WAS UNABLE TO PIN POINT A LEAK LOCATION. DRAPE SAVED AND SENT TO COMPANY FOR TESTS TO BE COMPLETED. VERIFIED WITH SCRUB NURSE THAT THERE WERE NO BLUNT/SHARP OBJECTS PLACED IN THE STERILE DRAPE AT ANY TIME. SURGEON MADE AWARE VIA EMAIL BY RESOURCE NURSE. DRAPE INFORMATION: SLUSH/WARMER DISC-DRAPE, REF#ORS-320, LOT#D143431.