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

Device Problems Decrease in Pressure (1490); Sticking (1597)

Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 03/13/2017

Event Type  Injury  

Manufacturer Narrative

The investigation was started but is not yet concluded.The investigation result will be reported in a follow up-report.

Event Description

It was reported that the expiration valve stuck during a case.The pressure graph appeared trapezoid and the pressure fell slower than expected during expiration.Due to this symptom the staff decided to cancel the case.Only one of two surgical treatments was completed at that time.The second one was postponed.

Manufacturer Narrative

After the reported event, the affected device was checked by a draeger service technician who also downloaded the electronic log file.Based on the information logged therein the case in question was started on (b)(6), at 2:42p.M.Until 3:10p.M., ventilation was stable in both volume- and pressure controlled modes with a constant peep of 5mbar.From 3:10p.M., the peep value increased to 8mbar.Although this may have been the result of user settings, this is rather the timeframe when the reported problems occurred.Within his device check, our service technician was able to reproduce the reported slow pressure decrease during expiration and determined that it was due to a sporadically sticking peep valve.During further inspection of the breathing system neither moisture nor any other contamination could be found, which could have restricted the function of the peep valve.The problem could be solved by re-assembling the peep valve assembly according to the latest draeger instructions which ensure that the diaphragm of the peep valve is mounted free of tension.Thus it was concluded that the reported event was due to unwanted tension within the peep valve diaphragm, which can result from an unfavorable assembly of the peep valve.In this context draeger introduced improved assembly instructions end of 2012.The affected device has already been repaired accordingly.The amount of similar cases is significantly below the values that provide basis for our risk management.Consequently, no further actions are required at this time.

Event Description

Please see initial-report.

• Brand Name: PRIMUS
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer Contact: sonja hillmer ; moislinger allee 53-55; lübeck 23542 ; GM 23542 ; 4518822868
• MDR Report Key: 6430903
• MDR Text Key: 70741974
• Report Number: 9611500-2017-00083
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K042607
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/31/2017

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2017
• Initial Date FDA Received: 03/24/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization