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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: D-VAPOR; ANESTHESIA UNIT VAPORIZERS
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D-VAPOR; ANESTHESIA UNIT VAPORIZERS Back to Search Results
Catalog Number M35500
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Chemical Exposure (2570)
Event Date 04/16/2021
Event Type  malfunction  
Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
 
Event Description
It was reported that a nurse who had filled up the vaporizer with anesthetic agent was exposed to evaporated agent when he removed the bottle at the end of the filling from the vaporizer.Since there was eye contact with the agent the nurse rinsed his eyes for 15-20 mins and returned to work the following day.
 
Manufacturer Narrative
The concerned device was not returned and, transmitted information in regard to the circumstances of occurrence is limited.Hence, dräger can only provide a general assessment which is based on evaluation of similar case reports received in the past.Filling of the vaporizer shall only be done by trained personnel and, following the filling procedure laid down in the ifu is imperatively necessary.Desflurane has a boiling point at room temperature.This requires that the filling port forms a gas-tight connection with the desflurane bottle contour when the latter is inserted into the port for filling; the tank valve of the vaporizer will be opened automatically during bottle insertion.The filling starts when the bottle is pressed down as described in the ifu (the bottle valve is opened) and ends when the pressure is released ¿ the bottle is driven back to an end position by spring force; the bottle valve closes, the tank valve is still not fully closed at this point in time.The user has to wait for a minimum of 2 or 3 seconds then to ensure that the small volume of liquid desflurane in the cavity of the filling port (max.3.5 ml) can flow into the tank.By pressing the release button afterwards the tank will be closed; the bottle can be removed safely.Removing the bottle instead too quickly will cause an interrupted rinsing ¿ the tank valve closes before the full amount of liquid between the valves can flow into the tank and, when the cavity is opened to ambient the residual quantity of desflurane is being released in a sudden evaporation.In none of the previously received case reports a technical issue with the vaporizer was found; a release of agent can be excluded if the rinsing time is observed.In individual cases the users had already admitted that they removed the bottle too quickly.Hence, the explanation of use error that has caused or contributed to the reported spraying applies for the particular case as well, most likely.
 
Event Description
It was reported that a nurse who had filled up the vaporizer with anesthetic agent was exposed to evaporated agent when he removed the bottle at the end of the filling from the vaporizer.Since there was eye contact with the agent the nurse rinsed his eyes for 15-20 mins and returned to work the following day.
 
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Brand Name
D-VAPOR
Type of Device
ANESTHESIA UNIT VAPORIZERS
MDR Report Key11956774
MDR Text Key259182393
Report Number9611500-2021-00244
Device Sequence Number1
Product Code CAD
Combination Product (y/n)N
PMA/PMN Number
K042276
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 06/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberM35500
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/12/2021
Initial Date FDA Received06/08/2021
Supplement Dates Manufacturer Received06/15/2021
Supplement Dates FDA Received06/17/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/31/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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