Catalog Number 50004 |
Device Problem
Chemical Problem (2893)
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Patient Problems
Asthma (1726); Itching Sensation (1943); Sneezing (2251); Pharyngitis (2367); Chest Tightness/Pressure (2463); 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).Are related complaints from the same facility.This is seven 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 evotech ecr units.No problems were found with the units and no odor was detected.This report is for healthcare worker (hcw) #7 whose symptoms included nasal congestion, hoarseness, coughing, sneezing, shortness of breath, chest tightness, itchy eyes and throat with pharyngitis.Hcw #7 has a history of asthma and experienced an exacerbated asthma condition.Hcw #7 was seen in the emergency room by a physician and prescribed an oral prednisone, cough suppressant and antibiotics as well as an increase to his inhaler.Hcw #7 stated his symptoms lasted approximately two (2) months and has since resolved.He reports personal protective equipment (ppe) of a gown, gloves, eye wear, and a mask was worn while performing his job duties.
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Manufacturer Narrative
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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.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 exchanges in the room from 10 to 17 per hour.The air exchanges were measured and found to be within specification.An industrial hygienist was contracted in (b)(4) 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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