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

Device Problems Use of Device Problem (1670); Device Handling Problem (3265)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that during a difficult operation, high mvleck values were displayed by the device.This led to a misinterpretation and to the initiation of measures to find the alleged leakage.A serious injury cannot be excluded based on the information available at this time.

Manufacturer Narrative

In order to gain a better understanding of the mvleck value, we would like to focus on the basic determination of the mvleck value, which is calculated as follows: mvleck= mvinsp - mvexsp - o2uptake + co2exsp.The o2 uptake is determined from the inspiratory and exspiratory patient gas measurements.The measurement method for the determination of mvinsp/mvexsp is based on the inspiratory and exspiratory flow measurement.Each measurement method is subject to individual tolerances.The mvleck value has (as described in the ifu) a tolerance of 15% based on mvexsp + mvleck, i.E.1.04 l/min with an indicated mv of 6.0 l/min and an mvleck display of 0.90 l/min, as indicated in the instructions for use.The specified tolerance gives an indication of the accuracy of the value so that it is possible to estimate the magnitude of the displayed mvleck.Accordingly, mvleck values of one liter and more (as reported) are not a wrongly displayed value.Furthermore, since the therapy decision should not only be made on the basis of individual measured values or monitoring parameters (as described in the instructions for use) a possible patient risk due to a supposedly too high mvleck value can be excluded.The mvleck value is located on the second monitor page.It is not displayed on the default page and must be explicitly selected by the user; is therefore not present at first glance for the user.Another decisive criterion regarding the relevance assessment of this value is that no triggering of alarms takes place on the basis of the mvleck value; this value therefore has no meaning for the alarm generation.A possible lack of fresh gas (e.G.Due to a leakage) can either be derived by the condition of the breathing bag or a corresponding alarm "leck or fg low" is generated by the device.In the further course, with an emptying of the reserve volume in the ventilator piston, additionally the alarms "vt not reached or pinsp not reached" are activated.Points listed above illustrate that the mvleck value is not an essential parameter.Other parameters are available, which are used for the alarm functionality and on which a therapy decision is also possible.In addition, the mvleck value is not required according to din en iso 80601-2-13 "additional requirements for anesthetic workstations".Therefore, if requested by the customer this value can be suppressed.Finally, it can be summarized that no malfunction of the primus has caused the reported event.Obviously the correct displayed mvleck value was misinterpreted by the user.

Event Description

Please refer to the 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
• MDR Report Key: 9422206
• MDR Text Key: 170265085
• Report Number: 9611500-2019-00414
• 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: 02/21/2020

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?: Yes
• Initial Date Manufacturer Received: 11/28/2019
• Initial Date FDA Received: 12/06/2019
• Supplement Dates Manufacturer Received: 01/28/2020
• Supplement Dates FDA Received: 02/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NA.; NA.
• Patient Outcome(s): Required Intervention