MAUDE Adverse Event Report: D-VAPOR; ANESTHESIA UNIT VAPORIZERS

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.

• Brand Name: D-VAPOR
• Type of Device: ANESTHESIA UNIT VAPORIZERS
• MDR Report Key: 11956774
• MDR Text Key: 259182393
• Report Number: 9611500-2021-00244
• Device Sequence Number: 1
• Product Code: CAD
• Combination Product (y/n): N
• PMA/PMN Number: K042276
• Number of Events Reported: 1
• 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

• Date FDA Received: 06/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M35500
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1