MAUDE Adverse Event Report: PRIMUS STERILIZER COMPANY LLC PRIMUS STEAM STERILIZER; STERILIZER, STEAM

Device Problems Burst Container or Vessel (1074); Fumes or Vapors (2529)

Patient Problem Headache (1880)

Event Date 04/26/2016

Event Type  malfunction  

Event Description

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.

• Brand Name: PRIMUS STEAM STERILIZER
• Type of Device: STERILIZER, STEAM
• Manufacturer (Section D): PRIMUS STERILIZER COMPANY LLC; 6565 south 118th street; omaha NE 68137
• MDR Report Key: 5619168
• MDR Text Key: 44008966
• Report Number: 5619168
• Device Sequence Number: 1
• Product Code: FLE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/27/2016
• Device Age: 5 YR
• Event Location: Other
• Date Report to Manufacturer: 04/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other