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

Catalog Number 8607500

Device Problems Failure to Sense (1559); Use of Device Problem (1670); No Apparent Adverse Event (3189); Misassembled During Installation (4049)

Patient Problem Respiratory Distress Syndrome of Newborns (2046)

Event Date 05/04/2021

Event Type  Injury  

Manufacturer Narrative

The investigation is still on-going.The results will be provided with a follow-up report.

Event Description

It was reported that during a caesarian section sevo was reading very low so that the flow and sevo concentration was increased.When the problem was fixed the correct readings showed that the patient was adequately anaesthetized and that the gas sensor has given inaccurate readings.This resulted in the baby receiving more anesthetic than it was necessary and it required inflation breaths at delivery.

Event Description

It was reported that during a caesarian section sevo was reading very low so that the flow and sevo concentration was increased.When the problem was fixed the correct readings showed that the patient was adequately anaesthetized and that the gas sensor has given inaccurate readings.This resulted in the baby receiving more anesthetic than it was necessary and it required inflation breaths at delivery.

Manufacturer Narrative

It was initially reported that the gas sensor has given inaccurate readings.In the course of investigation, this assumption could be denied.Based on the available information and the logfile analysis, a leakage between the water trap and the sensor unit behind it was the root cause.In case of such leakage, the patient gas is diluted with room are leading to the patient gas readings displayed lower than actual ones.As further reported, the user found the water trap not being pushed in properly and that the plastic arms that secure the water trap seemed very loose in the connection with the anaesthetic machine.The user reportedly resolved the issue by replacing the water trap.The instructions for use describe to hold the water trap at the fluted grips and insert it into the holder until it audibly clicks into place.The integrated patient gas monitoring ensures that deviations from set/expected parameters are obvious for the user and that alarms are given according to the set alarm limits.Neither ventilation nor gas dosage will be affected as gas readings are not used for control purpose.The user can derive the patient status from other vital parameters as well.Finally, based on the given information, it could be concluded that the reported issue was caused by a use error namely the water trap not being inserted in the specified way leading to a leakage and thus lower gas readings.

• 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: 11854046
• MDR Text Key: 251660224
• Report Number: 9611500-2021-00217
• 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: 07/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8607500
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention