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

Catalog Number MP05805

Device Problems Mechanical Problem (1384); Obstruction of Flow (2423)

Patient Problem Insufficient Information (4580)

Event Date 02/17/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient suffered a cardio respiratory arrest.The filter was completely condensed.

Manufacturer Narrative

For investigation laboratory tests were performed with the same filter type.No significant raise of resistance could be determined with deliberately caused condensate.The resistance requirement of =2mbar at a flow of 30l/min was fulfilled.Only a moist filter fleece showed increased resistance.However, this scenario do not reflect a realistic use case.The orientation of the filter has an impact on the formation of condensate.The horizontally mounted filter showed less condensate then the vertical mounted filter.Due to the limited information and no availability of log files or the filter itself, no root cause could be determined.An increased resistance or clogged filter is detected by the main device via pressure monitoring.An alarm is issued depending on the alarm limits set by the user.The alarm limits of the basic device must be set that they correspond to the therapy requirements.If the resistance is too high, the filter must be replaced immediately.The regional regulatory affairs & quality system administrator stated that "there is no relationship between the events you mention [cardio respiratory arrest] and the failures with our filters".Nevertheless, it cannot be excluded that the caused or contributed to the reported injury.

Event Description

It was reported that the patient suffered a cardio respiratory arrest.The filter was completely condensed.

• 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: 16741620
• MDR Text Key: 313296869
• Report Number: 9611500-2023-00141
• Device Sequence Number: 1
• Product Code: CAH
• Combination Product (y/n): N
• 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: 06/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MP05805
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NA.; NA.
• Patient Outcome(s): Life Threatening