inforMED
MalfunctionMEC

RELIANCE VISION SINGLE-CHAMBER WASHER DISINFECTOR

Received Jul 5, 2024 · Event occurred Jun 6, 2024

Report 9680353-2024-00022 · MDR key 19679748

Device

Generic name

Washer/disinfector

Manufacturer

Steris Canada Ulc

Product problems

  • Detachment of Device or Device Component
  • Detachment of Device or Device Component

Patient

NA · Unknown

  • Insufficient Information
  • Insufficient Information

Narrative

Additional Manufacturer Narrative

THE EMPLOYEE SHOULD HAVE TURNED OFF THE CONVEYOR SYSTEM PRIOR TO ATTEMPTING TO MANUALLY MOVE THE RACK. THE STERIS OPERATOR MANUAL STATES THE FOLLOWING IN ACCORDANCE WITH PERSONAL INJURY AND/OR EQUIPMENT DAMAGE HAZARD: "RISK OF CRUSHING OR PINCHING FINGERS OR HANDS. KEEP HANDS AWAY FROM ANY MOVING PART OR RACKS. RACKS, ROLLERS AND PNEUMATIC CYLINDERS CAN START IN MOTION AT ANY TIME DURING OPERATION" AND "IN CASE OF AN EMERGENCY SITUATION INVOLVING CONVEYORS, DEPRESSURIZE CONVEYOR LINE BY PRESSING PNEUMATIC PRESSURE-RELEASE PUSHBUTTON ON ANY CONVEYOR EQUIPPED WITH A PNEUMATIC CYLINDER. IF NO PRESSURE-RELEASE PUSHBUTTON IS INSTALLED, DEPRESSURIZE CONVEYOR LINE BY PRESSING EMERGENCY STOP PUSHBUTTON ON WASHER. IF WASHER IS NOT EQUIPPED WITH AN EMERGENCY STOP PUSHBUTTON, PUT CONTROL SYSTEM POWER ON/OFF SWITCH TO OFF." A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE UNIT AND FOUND THAT A BOLT FOR THE CONVEYER SYSTEM ARM WAS MISSING. AS THE BOLT WAS MISSING, THE CONVEYER SYSTEM ARM WAS NOT PROPERLY POSITIONED TO GRAB ONTO THE RACK AND MOVE IT FORWARD. THE TECHNICIAN REPLACED THE MISSING BOLT, TESTED THE CONVEYOR SYSTEM, CONFIRMED IT TO BE OPERATING ACCORDING TO SPECIFICATIONS, AND RETURNED THE UNIT TO SERVICE. THE TECHNICIAN COUNSELED USER FACILITY PERSONNEL ON THE PROPER USE AND OPERATION OF THE RELIANCE VISION SINGLE-CHAMBER WASHER/DISINFECTOR AND CONVEYOR SYSTEM, SPECIFICALLY ON SAFE OPERATING PROTOCOLS. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED THAT AN EMPLOYEE NOTICED THAT A RACK TO THEIR RELIANCE VISION SINGLE-CHAMBER WASHER/DISINFECTOR WAS NOT MOVING FORWARD ON THE CONVEYOR, AND THEY ATTEMPTED TO MANUALLY MOVE THE RACK. THE RACK MOVED FORWARD AS THE EMPLOYEE WAS PULLING ON IT AND THEN CONTACTED THE EMPLOYEE ON THE HEAD. THE USER FACILITY DID NOT DISCLOSE THE DETAILS OF THE INJURY OR IF ANY MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.