inforMED
MalfunctionFLE

PRIMUS STEAM STERILIZER

Received Apr 29, 2016 · Event occurred Apr 26, 2016

Report 5619168 · MDR key 5619168

Device

Generic name

Sterilizer, Steam

Product problems

  • Burst Container or Vessel
  • Fumes or Vapors

Patient

Not reported

  • Headache
  • Headache

Narrative

Description of Event or Problem

ANIMAL RESOURCE CORE TECHNICIAN UNLOADED THE PRIMUS AUTOCLAVE IN THE CAGE WASH ROOM IN RB3 VIVARIUM. SHE CLOSED THE DOOR TO THE AUTOCLAVE AND WAS LEAVING THE ROOM (APPROXIMATELY 10 SECONDS AFTER CLOSING THE DOOR), WHEN THE AUTOCLAVE EXPLODED. EMPLOYEE WAS NOT INJURED, BUT SHAKEN UP. REPORTING A HEADACHE FOR WHICH SHE TOOK TYLENOL (APPROX 12:35PM). ASKING EH (EMPLOYEE HEALTH) TO FOLLOW UP ON EMPLOYEE LATER TODAY - SHE HAS BEEN SENT HOME TO RECOVER. STEAM FILLED THE ROOM AND THE FIRE ALARMS WENT OFF AFTER ABOUT 1 MINUTE. SAFETY, CITY FIRE DEPARTMENT, ENGINEERING, FACILITIES AND BIOMED ALL RESPONDED TO CONTAIN, INVESTIGATE AND MITIGATE THE SITUATION UNTIL A COMPLETE INVESTIGATION CAN BE DONE. MANUFACTURER REPRESENTATIVES ON SITE WITHIN 24 HOURS OF THE INCIDENT FOR FULL INSPECTION. WILL FOLLOW UP WITH REMEDIATION RECOMMENDATIONS AS WELL AS A FULL REPORT OF FINDINGS. MANUFACTURER RESPONSE FOR STERILIZER, PRIMUS (PER SITE REPORTER): ON SITE VISIT 3/25. AGREE TO REMEDIATE THE ISSUE TO GET THE UNIT BACK UP AND RUNNING.