inforMED
MalfunctionFLE

PLATFORM STERILIZER

Received Mar 21, 2024 · Event occurred Feb 23, 2024

Report 3005899764-2024-00011 · MDR key 18952625

Device

Generic name

Sterilizer

Product problems

  • Leak/Splash
  • Leak/Splash

Patient

NA · Unknown

  • Burn(s)
  • Burn(s)

Narrative

Description of Event or Problem

THE USER FACILITY REPORTED THAT FOLLOWING A CYCLE AN EMPLOYEE'S FACE OBTAINED A BURN AFTER BEING CONTACTED BY STEAM WHEN THE CHAMBER DOOR WAS OPENED TO THEIR PLATFORM STERILIZER. THE EMPLOYEE SOUGHT MEDICAL TREATMENT AT THE ER, HOWEVER NO MEDICAL TREATMENT WAS ADMINISTERED.

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE UNIT AND FOUND THAT THE HEAT EXCHANGER WAS DAMAGED. AS THE HEAT EXCHANGER WAS DAMAGED, THIS RESULTED IN EXCESS STEAM TO BUILD UP IN THE STERILIZER'S CHAMBER RESULTING IN THE REPORTED EVENT. THE TECHNICIAN REPLACED THE HEAT EXCHANGER AND THE WATER PUMP. THE UNIT WAS TESTED, CONFIRMED TO BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.