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

Device Problems False Negative Result (1225); Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/23/2020

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 etco2 readings went down during a surgery which was confirmed by blood gas analysis.Medication was applied to stabilize the patient and, the surgery was aborted.

Manufacturer Narrative

The invesigation was performed based on the reported information.The users described that they found out that the water trap had not been adjusted properly.It had not snapped in on both sides.Such improper assembly may cause a leak between water trap and water trap adapter.Due to such leak the sampled gas may be dilluted with ambient air.This explains the observed drop in measured etco2.The investigation has not revealed any device failure.Incomplete assembly of the water trap was the root cause of the reported event.The water traps come with a description of the correct assembly.Given that, this case can be considered a use error.In case the sampled gas is dilluted with ambien air, the readings for all gases will deviate from the actual conditions at the y-piece, where the gas is sampled from.The gas readings are permanently displayed on the primus screen.Depending on the alarm limits adjusted by the user, corresponding alarms may be generated.

Event Description

It was reported that the etco2 readings went down during a surgery which was confirmed by blood gas analysis.Medication was applied to stabilize the patient and, the surgery was aborted.

• Brand Name: PRIMUS
• Type of Device: ANESTHESIA UNIT
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 10913627
• MDR Text Key: 218504144
• Report Number: 9611500-2020-00437
• 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: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/06/2020
• Initial Date FDA Received: 11/27/2020
• Supplement Dates Manufacturer Received: 01/04/2021
• Supplement Dates FDA Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention