MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA PRIMUS; ANESHESIA UNITS

Catalog Number 8603800

Device Problems Gas Output Problem (1266); Failure to Deliver (2338); No Flow (2991); Misassembly by Users (3133)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 12/04/2020

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 the user did not connect the breathing hoses properly.The patient was not ventilated and needed resuscitation.

Event Description

It was reported that the user did not connect the breathing hoses properly.The patient was not ventilated and needed resuscitation.

Manufacturer Narrative

It was not possible to identify the involved device in follow-up of the event.The user facility has transmitted log files for six devices.Analysis of the data revealed that only three of the logs were fully covering the date of event; no hints for potential misconnections could be found for the procedures performed on the relevant day.For another two devices the records for the date of event are partly overwritten with newer entries already, the captured data however gives no indication for the potential presence of ventilation problems during the performed surgeries.The log files for the sixth device are fully overwritten, unfortunately.Thus, no statement in regard to potential procedural impairments can be made.Involvement of five of the six devices into the event can nearly be excluded according to the log file data.A reliable conclusion cannot be made for the sixth device due to missing relevant information and, the reported observation can neither be confirmed nor denied.The user had admitted to have produced a misconnection of the patient circuit set-up which caused a pneumatic short-circuit.Per report this led to failure to supply the patient with gas until the error condition was detected.This would incorporate an unintended use error.Dräger concludes that appropriate risk mitigation measures are in place to detect this use error in advance or it's consequences after coming into effect: the manual part of the checklist includes an item requiring the check of proper connection of the patient circuit.The mandatory patient gas monitoring allows a permanent overview if the gas exchange of the patient is working or not; the atypical co2 trace is an indicator for a general problem in the particular case and, the low and continuously decreasing fio2 value demonstrates that the patient is not receiving any fresh gas.The device will alarm in pressure-controlled modes for flow apnea, in volume-controlled modes for pressure limited and vt not attained.All types of alarms, potential root causes and dedicated remedies are listed in the ifu.

• Brand Name: PRIMUS
• Type of Device: ANESHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 11327775
• MDR Text Key: 235026909
• Report Number: 9611500-2021-00067
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K042607
• 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: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8603800
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening