MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA FILTER SAFESTAR 55 PLUS; HEAT/MOISTURE EXCHANGER/ MICROBIAL MEDICAL GAS FILTER

Model Number	MP05790
Medical Device Problem Codes	Mechanical Problem (1384); Obstruction of Flow (2423)
Health Effect - Clinical Code	Bronchospasm (2598)
Date of Event	03/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported ¿sudden emergency situation: clinical situation appeared as a massive bronchospasm due to an anaphylactic reaction to the antibiotic cefuroxime, with ventilation pressures of 40 mbar only a vt of 20 - 120 ml, later partly up to 220 ml could be achieved, there was an immediate vital threat!!! correct tube position (laryngoscopic and brochoscopic position check, exclusion of a cuff hernia, no indication of aspiration, medication was given according to the guidelines, after switching to the evita 4 intensive care ventilator (new patient filter!) the patient could be ventilated immediately with normal pressures, the check of the anesthesia machine revealed no defects, but the anesthesia filter used (visually unremarkable) is only passable for air at high pressure.¿ according to additional information received, the operation was canceled due to the symptoms described above.
Additional Manufacturer Narrative
The investigation is still on-going.The results will be provided with a follow-up report.
Event or Problem Description
The following was reported ¿sudden emergency situation: clinical situation appeared as a massive bronchospasm due to an anaphylactic reaction to the antibiotic cefuroxime, with ventilation pressures of 40 mbar only a vt of 20 - 120 ml, later partly up to 220 ml could be achieved, there was an immediate vital threat!!! correct tube position (laryngoscopic and brochoscopic position check, exclusion of a cuff hernia, no indication of aspiration, medication was given according to the guidelines, after switching to the evita 4 intensive care ventilator (new patient filter!) the patient could be ventilated immediately with normal pressures, the check of the anesthesia machine revealed no defects, but the anesthesia filter used (visually unremarkable) is only passable for air at high pressure.¿ according to additional information received, the operation was canceled due to the symptoms described above.
Additional Manufacturer Narrative
It was reported that the symptoms of high filter resistance occurred at the same time as the patient's repositioning.From this it can be concluded that the filter did not exhibit increased resistance initially and at the start of therapy.Based on tests carried out, it could be shown that a significant increase in resistance could only be recreated by ¿overhead positioning¿ of the filter in conjunction with a larger amount of condensate.It can be assumed that the repositioning of the patient could have led to the scenario described and consequently to clogging of the filter.The affected filter was available for examination.A resistance measurement carried out immediately after arrival showed 3.5 mbar.This is outside the specification of < 2mbar, but still allows adequate ventilation.The high resistance described by the user could not be confirmed and can be explained by the drying of the filter paper during shipping.The slightly increased resistance value that was nevertheless detected is probably due to residual moisture in the filter.The instructions for use state that the filter must be replaced if liquid appears on the device side.If the filter is blocked, the airway pressure will increase and it may not be possible to apply the set volume.Depending on the alarm limits set by the user, a corresponding alarm is issued by the connected main device.The alarm limits of the main unit must be set so that they correspond to the therapy requirements.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

• Brand Name: FILTER SAFESTAR 55 PLUS
• Common Device Name: HEAT/MOISTURE EXCHANGER/ MICROBIAL MEDICAL GAS FILTER
• 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: 21580868
• Report Number: 9611500-2025-00119
• Device Sequence Number: 18359889
• Product Code: BSZ
• UDI-Device Identifier: 04048675558736
• UDI-Public: (01)04048675558736
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2025

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
• Operator of Device: Health Professional
• Device Model Number: MP05790
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/05/2025
• Supplement Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown