AMSCO
Received Oct 24, 2024 · Event occurred Sep 24, 2024
Report 3005899764-2024-00056 · MDR key 20527749
Device
Generic name
Amsco 600 Steam Sterilizer
Manufacturer
Steris Mexico, S. De R.l. De C.v.Model number
AMSCO 600 STEAM STERILIZERCatalog number
EF1301122
Product problems
- Leak/Splash
- Leak/Splash
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A STERIS SERVICE TECHNICIAN INSPECTED THE AMSCO 600 STERILIZER AND FOUND THAT THE WATER HOSE FROM THE PURE WATER LINE HAD DISCONNECTED SUBSEQUENTLY CAUSING THE REPORTED EVENT TO OCCUR. THE STERIS SERVICE TECHNICIAN FURTHER INSPECTED THE HOSE AND FOUND THAT THE HOSE HAD AN INCORRECT FITTING SPECIFICALLY, THE HOSE CLAMP WAS NOT CRIMPED. THIS IS INTENDED TO BE DONE DURING THE INSTALLATION PROCESS. THE STERIS SERVICE TECHNICIAN REPLACED THE HOSE, TESTED THE FUNCTION AND OPERATION OF THE AMSCO 600 STERILIZER, CONFIRMED IT TO BE OPERATING PROPERLY, AND RETURNED IT TO SERVICE. ADDITIONALLY, THE SERVICE TECHNICIAN CONFIRMED PROPER HOSE INSTALL AND FITTINGS FOR ALL AMSCO 600 STERILIZERS AT THE USER FACILITY. NO OTHER ISSUES WERE IDENTIFIED. THE STERIS SERVICE TECHNICIAN WHO INSTALLED THE AMSCO 600 STERILIZER WAS RETRAINED ON THE PROPER INSTALLATION PROCEDURES AND THE IMPORTANCE OF ENSURING THE HOSE IS PROPERLY CRIMPED AND SECURED. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.
Description of Event or Problem
THE USER FACILITY REPORTED THAT WATER WAS LEAKING FROM THEIR AMSCO 600 STERILIZER. NO REPORT OF INJURY.