MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA D-VAPOR; ANESTHESIA UNIT VAPORIZERS

Catalog Number M35500

Device Problems Leak/Splash (1354); Device Handling Problem (3265)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/23/2021

Event Type  malfunction  

Manufacturer Narrative

The device is owned/operated by the baxter healthcare company, the manufacturer of the anesthetic agent.Despite multiple requests, dräger has not received the involved device for evaluation nor any detail about potential findings/repair measures.Initially, the case was assessed as not reportable.This was based on experience with the few known similar incidents in which the investigation always came to the conclusion that the agent release was related to operator misbehavior; in none of the cases was a technical issue with the involved device identified.This decision was revised after a telephone call with the head of the biomedical department of the hospital.Mr.(b)(4) reported that the nurse who filled the device is very experienced in doing this procedure.Furthermore was disclosed that the agent release at this device happened twice in a span of a few days.Operator misbehavior can still not be fully excluded but is rated rather unlikely after receipt of these new details.A reliable conclusion in regard to the root cause is not possible due to not having the possibility to evaluate the involved device.Dräger finally concludes that appropriate risk mitigation measures are in place - adequate training material describing the filling process is available and, the use of ppe during the filling process is recommended in the ifu.The number of similar cases is within the expected range of the respective risk assessment and thus accepted.

Event Description

It was reported that there was a release of anesthetic agent at the end of the filling process.A nurse was exposed to the chemical but reportedly, this did not lead to health consequences.

Event Description

It was reported that there was a release of anesthetic agent at the end of the filling process.A nurse was exposed to the chemical but reportedly, this did not lead to health consequences.

Manufacturer Narrative

Due to a technical issue with our internal emdr system we submitted for the form fda 3500a an incorrect value for the field h3.- not returned to manufacturer.

• Brand Name: D-VAPOR
• Type of Device: ANESTHESIA UNIT VAPORIZERS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 12758175
• MDR Text Key: 282413526
• Report Number: 9611500-2021-00453
• 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: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Device Age: 12 YR
• Date Manufacturer Received: 10/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2009
• 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