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

Catalog Number 8603800

Device Problems Gas Output Problem (1266); Misassembled (1398); Use of Device Problem (1670); Output Problem (3005); Misassembly by Users (3133)

Patient Problem Cyanosis (1798)

Event Date 09/29/2020

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 at the beginning of a case the fio2 dropped to 19%.The patient reportedly desaturated and became cyanotic.

Event Description

It was reported that at the beginning of a case the fio2 dropped to 19%.The patient reportedly desaturated and became cyanotic.

Manufacturer Narrative

It was started at 8:19 using man/spont.At the beginning an inspiratory oxygen concentration (ino2) of 25% was measured.In the following no ventilation (no pressure, no volume) was detected and the device consequently generated audible and visible mv low alarms, informing the user about low minute volume.The measured inspiratory o2-concentration decreased within the following minutes to 16% at 8:23.The device repeatedly posted insp.O2 low alarms.At 8:24 the unit was switched to standby.According to the consumption data 47l oxygen were delivered by the gas mixer during the 5 minutes of manual ventilation.This goes along with the description of the user (10 l/min ¿ 100% o2).From 8:25 the procedure was continued using man/spont again.Just from the beginning an inspiratory o2-concentration of more than 90% was measured.At 8:28 the user switched to volume af mode.Ventilation was unremarkable and stable for the rest of the case.At 12:13 the unit was finally switched in standby.The log does not indicate any kind of device failure.The absence of further alarms like o2 supply pressure low (in case the pipe- or cylinder pressure is too low) and no o2 supply provides evidence the o2 supply was present.The electronic gas mixer was fully functional during the case in question and supplied the set oxygen fresh gas flow at any time.The exact root cause could not be determined with certainty but a plausible explanation is that the patient wasn¿t connected to the breathing system properly.

• Brand Name: PRIMUS
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 10754953
• MDR Text Key: 213651973
• Report Number: 9611500-2020-00384
• 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: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2020
• 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: 12/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NA.; NA.
• Patient Outcome(s): Life Threatening