Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA SET2GO ANESTHESIA; BREATHING HOSE, DISPOSABLE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DRÄGERWERK AG & CO. KGAA SET2GO ANESTHESIA; BREATHING HOSE, DISPOSABLE Back to Search Results
Catalog Number MP07958
Device Problem Gas Output Problem (1266)
Patient Problem Bronchospasm (2598)
Event Date 04/12/2021
Event Type  Injury  
Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
 
Event Description
It was reported that a new coaxial tubing system was connected to the anesthesia machine on 28th of march.With this assembly several successful procedures were performed.On 8th of april the anesthesia machine was successfully tested, at 8 o'clock the relevant procedure was started.Intravenous induction of anesthesia with mask ventilation proceeded without problems.After insertion of the laryngeal mask, the patient could not be ventilated, so he was intubated immediately.Ventilation via the endotracheal tube was only possible manually with high pressures and small tidal volumes.Capnometry indicated high expiratory co2 pressures.Correct position of the tube and if it is free from blockages were checked and confirmed.Ventilation tubes were connected correctly.Hypoxia was ruled out by pulse oximetry and abg.Clinically, the situation appeared primarily like severe bronchospasm, and appropriate therapy was started.Ventilation was performed with high fio2, manually, with small tidal volumes, and further high expiratory pco2.Normal ventilation was only possible with the separate breathing bag.No permanent patient damage occurred: the short-duration palliative surgery could be performed despite the problems.The patient was oriented and stable the following day.The coaxial tubing system was checked, and the inner tube was found twisted.
 
Manufacturer Narrative
For the investigation, the hose system in question was requested and provided.During the analysis at the manufacturer the described problem could be confirmed.It was found that the adhesive connection of the outer hose had come loose.This allowed the inner hose, which was firmly connected to the connector, to twist during use.An error during the bonding process in production was identified as the root cause.The adhesive is applied to the connector in a semicircle and distributed by circular movements when the hose is attached.Insufficient bonding of the hoses or a broken adhesive connection can result in reduced adhesion of the hose to the respective connector.This can additionally be favored by an insufficient amount of adhesive.The manufacturer has initiated additional training for employees regarding the bonding process and has ramped up visual inspection to 100% during packaging.The user is instructed in the instructions for use to inspect the breathing tube before use.This is the first case reported to dräger.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.
 
Event Description
It was reported that a new coaxial tubing system was connected to the anesthesia machine on 28th of march.With this assembly several successful procedures were performed.On 8th of april the anesthesia machine was successfully tested, at 8 o'clock the relevant procedure was started.Intravenous induction of anesthesia with mask ventilation proceeded without problems.After insertion of the laryngeal mask, the patient could not be ventilated, so he was intubated immediately.Ventilation via the endotracheal tube was only possible manually with high pressures and small tidal volumes.Capnometry indicated high expiratory co2 pressures.Correct position of the tube and if it is free from blockages were checked and confirmed.Ventilation tubes were connected correctly.Hypoxia was ruled out by pulse oximetry and abg.Clinically, the situation appeared primarily like severe bronchospasm, and appropriate therapy was started.Ventilation was performed with high fio2, manually, with small tidal volumes, and further high expiratory pco2.Normal ventilation was only possible with the separate breathing bag.No permanent patient damage occurred: the short-duration palliative surgery could be performed despite the problems.The patient was oriented and stable the following day.The coaxial tubing system was checked, and the inner tube was found twisted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SET2GO ANESTHESIA
Type of Device
BREATHING HOSE, DISPOSABLE
Manufacturer (Section D)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck 23542
GM  23542
MDR Report Key11751610
MDR Text Key249803510
Report Number9611500-2021-00184
Device Sequence Number1
Product Code OFP
Combination Product (y/n)N
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
Date FDA Received04/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberMP07958
Was Device Available for Evaluation? Yes
Date Manufacturer Received06/04/2021
Is This a Reprocessed and Reused Single-Use Device? Yes
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Other;
-
-