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

Model Number 5XL

Device Problems Device Displays Incorrect Message (2591); Insufficient Information (3190)

Patient Problems Headache (1880); Respiratory Distress (2045); Dizziness (2194)

Event Date 08/22/2014

Event Type  Injury  

Event Description

A manager of the hospital sterile processing department was working with a service technician on 3m steri-vac sterilization/aerator 5xl on (b)(6) 2014.The technician opened the door of the sterilizer.Ethylene oxide allegedly escaped into the room.The technician promptly closed the door.Both the technician and the customer left the room.The customer alleged that he felt light-headed, dizzy, and felt his heart racing.He went outside and then to the hospital occupational health clinic who performed a chest x-ray, ekg and took his blood pressure.On (b)(6) he awoke feeling dizzy and light-headed.He improved enough to drive but then alleged that he felt a lack of air, was sweating, and had a pounding heart.He drove himself to the emergency room where they performed a chest x-ray, ekg and took his blood pressure.He was given an unidentified iv and discharged.He went home with a headache and dizziness for the rest of the evening and took ibuprofen.By (b)(6) he returned to work but he alleged that he did not feel 100% recovered.At the beginning of (b)(6) 2014 the 3m steri-vac unit started making a loud noise.User facility called the 3m service technician.3m service technician came to the hospital the next day after call to clean the unit.On (b)(6) the sterile processing staff ran one item through the steri-vac and called 3m service technician due to an e78 code displaying on the steri-vac.User facility personnel shut the steri-vac off.On (b)(6) 2014 the steri-vac was serviced.The door was open for about 10 seconds to adjust the inner scan (unclear-rf).Signals skyrocketed and the alarm went off.(b)(6) within the user facility called the operating room to inform them of the ethylene oxide leak.

Manufacturer Narrative

Without the s/n it is not possible to determine the manufacturing date of the device.This information was not included in initial report.Issue associated with a device prompting user with an error message in order to indicate a device problem.The interaction between the device and the user caused or contributed to the error.This includes inappropriate use of the device or failure to appropriately maintain the device.Note: device was undergoing servicing and did not need to be returned to manufacturer for evaluation.

• Brand Name: 3M STERI-VAC STERILIZATION/AERATOR XL
• Type of Device: ETHYLENE OXIDE GAS STERILIZER
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave.; st. paul MN 55144
• Manufacturer (Section G): 3M COMPANY; 1617 north front st.; new ulm MN 56073
• Manufacturer Contact: linda johnsen ; 3m center, building 275-5w-6e; st. paul, MN 55144 ; 6517374376
• MDR Report Key: 4136223
• MDR Text Key: 4929899
• Report Number: 2110898-2014-00067
• Device Sequence Number: 1
• Product Code: FLF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K902036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 08/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 5XL
• Device Catalogue Number: 5XLP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/27/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR