MalfunctionLHC
ORS-100 SOLUTION WARMER DRAPE
Received Aug 11, 2016
Report 8043817-2016-00042 · MDR key 5868202
Device
Product problems
- Melted
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS NOT RETURNED FOR EVALUATION. AS NO DEVICE WAS RETURNED FOR EVALUATION, THE ROOT CAUSE OF THIS ISSUE COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE FILED.
Description of Event or Problem
THERE IS A SIZABLE CHUNK OF DRAPE MELTED ONTO THE BOTTOM OF THE SOLUTION WARMER. THE SOLUTION STERILITY WAS COMPROMISED HOWEVER NO PATIENT INJURY WAS REPORTED. THE SOLUTION WARMER WAS TESTED BY BIOMED DEPARTMENT AND WAS WITHIN SPEC.