ORS-320 SLUSH WARMER DISC DRAPE
Received Nov 22, 2017 · Event occurred Mar 30, 2017
Report 8043817-2017-00032 · MDR key 7052795
Device
Generic name
Fluid Warming And Slush Drapes
Manufacturer
Microtek Dominicana, S.a.Model number
ORS-320Lot number
UNKNOWN
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
NO SAMPLES WERE RETURNED FOR THIS INVESTIGATION AND A LOT NUMBER WAS NOT PROVIDED TO PERFORM A DHR REVIEW. SINCE NO LOT NUMBER OR SAMPLE WAS PROVIDED THE NON CONFORMITY COULD NOT BE CONFIRMED. IT WAS NOT DETERMINED IF THIS ISSUE WAS RELATED TO 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. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.
Description of Event or Problem
END USER REPORTED " SURGERY COMPLETED IN 501, DURING CLEAN UP AFTER CASE, IT WAS NOTED THAT THERE WAS IRRIGATION FLUID IN THE BOTTOM OF THE FLUID WARMER, UNDERNEATH THE DRAPE. THIS WOULD INDICATE THERE WAS A HOLE IN THE FLUID WARMER DRAPE USED DURING THE SURGICAL PROCEDURE. THERE IS NO WAY TO KNOW WHEN THE HOLE OCCURRED. UNABLE TO PULL LOT NUMBER FROM DRAPE, PACKAGE HAD ALREADY BEEN DISCARDED." NO PATIENT INJURY OR TREATMENT WAS REPORTED FOR THE INCIDENT.