MalfunctionLHC
HUSH SLUSH UNIT
Received Jun 12, 2019
Report 8043817-2019-40025 · MDR key 8691305
Device
Product problems
- Mechanical Problem
- Mechanical Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING AN OPEN HEART SURGERY, THE FUSE ASSEMBLY OF THE SLUSH CONSOLE SYSTEM HAD SHORTED OUT, SENDING SPARKS, SMOKE AND HOT METAL AROUND THE AREA. THE SMOKE WAS EVACUATED BY THE LAMINAR AIR SYSTEM, THOUGH SOME COULD HAVE ENTERED THE SURGICAL FIELD. THE CONSOLE WAS SEQUESTERED. IT WAS NOTED THAT THE CONSOLE WAS 21 YEARS OLD AND HAD A USEFUL LIFE OF OVER 10 YEARS WHEN USED BY THE FACILITY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.