MalfunctionLHC
ECOLAB
Received Sep 25, 2024 · Event occurred Mar 1, 2024
Report 20300464 · MDR key 20300464
Device
Generic name
Warmer, Irrigation Solution
Manufacturer
Microtek Medical Inc.Model number
HUSH SLUSH EQUIPMENTCatalog number
ORS-331
Lot number
2123LA2000
Patient
59 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
SMALL HOLE IN DRAPE NEAR PLATE, CAUSING CONTAMINATION TO SALINE. SALINE USED TO PRIME PERFUSION PUMP LINER PRIOR TO KNOWLEDGE OF HOLE, PERFUSION PUMP HAD TO BE BROKEN DOWN AND SET UP AGAIN, CONTAMINATED AREAS REPLACED. RETURNED TO MANUFACTURER.