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

Catalog Number 8603800

Device Problems Partial Blockage (1065); Increase in Pressure (1491); Tidal Volume Fluctuations (1634)

Patient Problems Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Low Oxygen Saturation (2477)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported to dräger that the users noted during a surgical procedure a drop in tidal volumes and rise in airway pressure.The patient's spo2 decreased temporarily but came back up after turning fresh gas mix to 100% o2.Users were performing several diagnostic steps to identify the root cause for the deterioration of patient status.The patient experienced a period of significant hypotension and tachycardia requiring the administration of a high dose of vasopressor.When the users switched from the initially used patient circuit to an external non-rebreathing system (waters) the ventilation was possible again.Further examination of the set-up revealed that the original patient circuit system had a partial occlusion.This was then associated to a situation immediately before the course of event started - another medical device was moved on its trolley aside of the anesthesia workstation and the casters must have damaged the inspiratory limb of the patient circuit system which was hanging down to the floor.Patient's high lactate/acidosis settled overnight enabling extubation next day.Discharge home was decided on day 3 with no obvious additional health consequences.

Manufacturer Narrative

The operator describes an use error that could have been avoided by protective guards fitted to the wheels of the cart which prevent from tubes and cables getting under the wheels.One example for such guard is a product named castrgard.Castrgards are available for order since 09/2007 - both for new ordered devices (optional) as well as for installed devices as an accessory.For this purpose the product is listed the in primus & more accessory catalogue.Dräger finally concludes that a customer decision to use such guards is well-supported by dräger already.

Event Description

Pease refer to initial mfr.Report.

• 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: 8801677
• MDR Text Key: 151409551
• Report Number: 9611500-2019-00211
• 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: 09/09/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2000
• Device Catalogue Number: 8603800
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/11/2019
• Initial Date FDA Received: 07/18/2019
• Supplement Dates Manufacturer Received: 08/26/2019
• Supplement Dates FDA Received: 09/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NA.; NA.
• Patient Outcome(s): Life Threatening