ORS-100 FLUID WARMER DRAPE
Received Oct 12, 2017 · Event occurred Sep 11, 2017
Report 8043817-2017-00028 · MDR key 6946450
Device
Generic name
Fluid Warming And Slush Drapes
Manufacturer
Microtek Dominicana, S.a.Model number
ORS-100Lot number
D171141
Product problems
- Hole In Material
- Hole In Material
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
A SAMPLE WAS RECEIVED FOR EVALUATION. THE SAMPLE DRAPE HAD A SMALL BURN MARK/HOLE ABOUT THREE INCHES FROM THE CENTER OF THE DRAPE. THE DHR WAS REVIEWED FOR LOT D171141 AND IT WAS NOTED THAT THIS LOT HAD (B)(4) PCS THAT WERE MANUFACTURED ON 04/24/2017. NO DEFECTS WERE REPORTED DURING QUALITY INSPECTIONS. BASED ON THE DHR AND SAMPLE REVIEW THIS ISSUE DOES NOT APPEAR TO BE THE RESULT OF A PERSONNEL, PROCESS, OR MATERIAL ISSUE. MELTS, THOUGH UNCOMMON, CAN OCCUR WHEN THE WARMER IS NOT DRAPED PROPERLY, NOT TURNED OFF BY USING THE POWER BUTTON, AND/OR THERE IS INSUFFICIENT FLUID IN THE WARMER BASIN, CONTRARY TO THE OPERATIONS MANUAL, PRODUCT LABELING, PRODUCT INSERT AND IN-SERVICE PRESENTATIONS. BECAUSE THIS APPEARS TO BE RELATED TO MISUSE BY THE CUSTOMER NO ACTIONS ARE BEING TAKEN AT THIS TIME.
Description of Event or Problem
END USER REPORTED THAT WATER WAS FOUND IN THE BASIN OF AN ORS IRRIGATION FLUID WARMER FOLLOWING THE COMPLETION OF AN ORTHO CASE. END USER STATED THAT NO SHARPS WERE INTRODUCED INTO THE DRAPE/BASIN DURING THE CASE. NO PATIENT INJURY OR TREATMENT WERE REPORTED FOR THE INCIDENT.