MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA FILTER, DISPOSABLE

Catalog Number MP05801

Device Problems Imprecision (1307); Decreased Sensitivity (2534)

Patient Problem Bronchospasm (2598)

Event Date 05/27/2023

Event Type  Injury  

Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report.H3 other text : on-going.

Event Description

It was reported that during a robotic prostate surgery a twinstarhepa plus was placed to the patient side.While starting anesthesia, the co2 waveform looks similar to bronchospasm, making the doctor think that the patient's airway has a problem.Therefore, the anesthesiologist administered bronchodilators several times, but the co2 waveform remained unchanged.When the anesthesiologist decided to change the filter back to the old version the waveform returned to normal.

Manufacturer Narrative

The affected filter of type "twinstar hepa plus" was requested for investigation but was not made available.The reported symptom was analysed in the laboratory with the same type of filter.It was found that the curve of the co2 concentration in the exhaled air of the expiration phase approaches the final value more slowly and therefore reaches the plateau of the maximum value with a slight delay compared to the predecessor model twinstar hepa.However, the maximum value reached is identical.A simulation of the flow conditions showed that the angular housing shape, together with the geometry of the pleat pack, caused that the exhaled air reaches the gas sampling nozzle later than in the round housing of the predecessor product.This resulted in a lower but noticeable damping of the capnography waveform.The damping does not lead to any distortion of the measured or calculated values of the clinically relevant reference points of the capnography curve.Finally, the reported symptom could be comprehended but does not indicate a malfunction of the filter.Since start of sales in (b)(6) 2022, no comparable case for the twinstar hepa plus has been reported.Compared to a number of 356.000 filters sold this is rated as acceptable.

Event Description

It was reported that during a robotic prostate surgery a twinstarhepa plus was placed to the patient side.While starting anesthesia, the co2 waveform looks similar to bronchospasm, making the doctor think that the patient's airway has a problem.Therefore, the anesthesiologist administered bronchodilators several times, but the co2 waveform remained unchanged.When the anesthesiologist decided to change the filter back to the old version the waveform returned to normal.

• Brand Name: FILTER, DISPOSABLE
• Type of Device: FILTER, DISPOSABLE
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 17223442
• MDR Text Key: 318073197
• Report Number: 9611500-2023-00244
• Device Sequence Number: 1
• Product Code: CAH
• Combination Product (y/n): N
• PMA/PMN Number: K221836
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MP05801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention