MAUDE Adverse Event Report: 3M HEALTH CARE 3M STERI-VAC ETHYLENE STERILIZER/AERATOR; STERILIZER, ETHYLENE-OXIDE GAS

Model Number 8XL

Device Problems Leak/Splash (1354); Device Displays Incorrect Message (2591)

Patient Problem Not Applicable (3189)

Event Date 01/15/2014

Event Type  malfunction  

Event Description

During routine operation, it was reported that an 8xl 3m steri-vac ethylene sterilizer displayed an error code (e71) that triggered the unit's audible alarm.Simultaneously with this alarm the user's provided eo monitor sounded indicating the presence of eo within the operators room.The individuals within the room left immediately resulting in no reported injury or eo exposure.

Manufacturer Narrative

The report pertains to a malfunction of the device.This type of failure would always result in an audible sound.The defective part involved in this incident is no longer used in manufacturing and was replace din late 2007 with a new part.The new part's brass bushing and seal is securely fastened onto the mating pocket of the cylinder.3m continues to investigate the failed part and related event to determine if additional actions are warranted.Any additional actions and findings weill be shared with fda under a supplemental report to this initial report.The unit involved in this event was not returned to the company.The defective part was replaced with the new part (implemented in late 2007) performed under a service repair which took place within the hospital facility.

• Brand Name: 3M STERI-VAC ETHYLENE STERILIZER/AERATOR
• Type of Device: STERILIZER, ETHYLENE-OXIDE GAS
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave.; st. paul MN 55144 100
• Manufacturer (Section G): 3M COMPANY; 1617 north front st.; new ulm MN 56073
• Manufacturer Contact: linda johnsen, reg. affairs ; 3m center, bldg. 275-5w-06; st. paul, MN 55144-1000 ; 6517374376
• MDR Report Key: 3881240
• MDR Text Key: 4567306
• Report Number: 2110898-2014-00013
• Device Sequence Number: 1
• Product Code: FLF
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K941748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 01/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8XL
• Device Catalogue Number: 8XL
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/1996
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1