MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA INFINITY ACS WORKSTATION NC; VENTILATORS, INTENSIVE CARE, NEONATAL /PEDIATRIC

Catalog Number 8415000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

The investigation has just started; results will be provided in a follow up-report.

Event Description

Dräger was notified that the director of infection control wanted to discuss the inner workings of the vn500 as in (b)(6) 2018 a patient contracted burkholderia cepacia complex.It was communicated that the only area on the machine that could potentially contain a contaminant for swabbing purposes was the inspiratory valve.The customer has since contacted the cdc and continues their investigation.Dräger was informed that once the lab results are back, it will be contacted with said results.The specific device used during the event was not reported.

Manufacturer Narrative

The mentioned device vn500 (complete name: infinity acute care system workstation neonatal care) is an intensive care ventilator for neonatal and pediatric use.The user initially suspected that the inspiratory unit could contain a contaminant.Therefore swabs have been taken by the customer which were sent in for analysis to an external lab.After the results came back, dräger was informed by the customer that these were negative.Therefore the inspiratory unit of the device can be excluded as the source of the contamination.In general the technical design of the infinity acute care system workstation neonatal care supports disassembly and hygienic reprocessing.Corresponding procedures are described in the instructions for use (ifu).Especially for infectious patients the ifu states that all parts that come into contact with breathing gas also have to be sterilized after disinfection and cleaning.Specifically for the inspiratory unit the ifu points out machine cleaning with thermal disinfection and steam sterilization in case breathing gas has passed through the safety valve.Based on the reported information and the provided lab results, draeger does not see a relation between the reported infections and the infinity acute care system workstation neonatal care.

Event Description

Please refer to the initial-report.

• Brand Name: INFINITY ACS WORKSTATION NC
• Type of Device: VENTILATORS, INTENSIVE CARE, NEONATAL /PEDIATRIC
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 8407178
• MDR Text Key: 138354925
• Report Number: 9611500-2019-00076
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K093632
• 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: 04/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2000
• Device Catalogue Number: 8415000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NA.; NA.
• Patient Outcome(s): Life Threatening