Catalog Number 50004 |
Device Problem
Chemical Problem (2893)
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Patient Problems
Itching Sensation (1943); Nausea (1970); Rash (2033); Sneezing (2251); Chemical Exposure (2570); No Code Available (3191)
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Event Date 12/22/2015 |
Event Type
Injury
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Manufacturer Narrative
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Since the source of the vapors in the room cannot be clearly identified and the evotech ecr and cidex opa-c solution were both used in the room, asp has decided to report this event out of an abundance of caution.(b)(4).This is three of seven 3500a reports being submitted for this serious injury.Please reference manufacture report numbers: 2084725-2016-00032, 2084725-2016-00033, 2084725-2016-00034, 2084725-2016-00035, 2084725-2016-00036, 2084725-2016-00037, 2084725-2016-00038.(b)(4).
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Event Description
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A customer reported seven (7) healthcare workers are experiencing respiratory symptoms and eye irritation from vapors in the endoscopy room of their facility.They state they are unsure what is causing the vapors in the room, and it is uncertain whether or not a chemical spill contributed to this.The customer also reported there is poor ventilation in the room and are investigating this.The room consists of two evotech endoscopic cleaner and reprocessors (ecrs) with cidex opa-c solution that is contained within the unit.In addition, the customer reports they manually soak and clean their instruments using metricide opa solution in an open basin prior to putting in the evotech ecr.An advanced sterilization products (asp) field service engineer (fse) was dispatched to the site to inspect and service the evotechcr units.No problems were found with the units and no odor was detected.This report is for healthcare worker (hcw) #3 whose symptoms included nasal congestion, sneezing, hoarseness, coughing, nausea, lightheadedness, and itching and redness of arms and head.Hcw #3 did not see a doctor for her symptoms and was not prescribed any additional medications as a result of this event.The healthcare worker reports personal protective equipment (ppe) of a gown, gloves, eye wear, and a mask is worn while performing their job duties.
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Manufacturer Narrative
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It was initially reported there were seven (7) healthcare workers experiencing symptoms.It was later reported there was one additional healthcare worker who reported symptoms.This is captured on (b)(4), manufacture report number 2084725-2016-00079.Corrected usage of device from "initial usage of device" to "reuse".Asp investigation summary: the investigation included a review of the device history record (dhr) and system risk analysis (sra).The dhr was reviewed and the unit met manufacturer specifications at the time of release.No issues were related to this failure mode.The sra was reviewed for the issue of "respiratory reaction" with "exposure to toxic and corrosive material" and the risk was determined to be low.The sra was reviewed for the issue of "skin/bone reaction" with "exposure to toxic and corrosive material" and the risk was determined to be low.Upon further follow-up, the customer states the following steps were taken to resolve the issue: the air ventilation system in the room was re-vented to the outside which increased the air exhanges in the room from 10 to 17 per hour.The air exhanges were measured and found to be within specification; an industrial hygienist was contracted in january 2016 to review and evaluate their processing procedures and meet with each healthcare worker to ensure proper procedures are being followed.The customer states they are no longer experiencing issues.No problem could be found in regards to the functionality of the evotech¿ ecr.The likely assignable cause can be attributed to poor ventilation, however, this could not be verified.The issue will be tracked and trended.No further investigation is necessary at this time.
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Search Alerts/Recalls
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