MAUDE Adverse Event Report: VYAIRE MEDICAL GMBH MICROGARD II BACT/VIRAL FILTER; FILTER, BACTERIAL, BREATHING-CIRCUIT

Model Number	MICROGARD II BACT/VIRAL FILTER
Medical Device Problem Codes	Failure to Calibrate (2440); Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is submitted late because it was originally assumed that the misplaced filter lining would be obvious to the customer and could not be overlooked.After re-assessing the complaint, it was decided to classify the incident as a reportable event.A clinical risk assessment resulted in a possible critical severity of harm.The probability of the situation leading to the harm (p2) is somewhat likely.Thus, this malfunction is reportable to the fda as it is not unlikely to cause or contribute to a death or serious injury if the malfunction were to recur.The customer provided a picture of an unpackaged microgard filter which have been delivered to the customer with a misplaced filter-lining.Therefore the complaint could be confirmed and the root-cause can be attributed to manufacturing / supplier quality issue.The supplier riensch & held gmbh & co.Kg.Provided a statement regarding the mitigation measures for each production line.It has been confirmed that all three production lines have built-in and effective mitigation measures to avoid the production from filters without bacterial/viral filter inlay.No scar necessary for supplier riensch & held gmbh & co.Kg.Corrective and preventive actions were implemented by the supplier on 01/26/2022.The supplier will be contacted to confirm that the affected filter was produced before the preventive and corrective actions took place or if new actions need to be initiated by the supplier.A follow-up report will be submitted as soon as further information is available.
Event or Problem Description
The customer complained that the filter-lining of the microgard filter is misplaced.This was noticed during an incoming inspection.There was no indication that defective filters were used for patient measurements.
Additional Manufacturer Narrative
It was determined that the statement of the supplier wasn't fitting to the type of this complaint.It was assumed that a missing filter fleece would have the same mitigation measures for each production line as a misplaced filter lining.Therefore the supplier (b)(4) was contacted again for a more specific statement.The supplier implemented the following improvements to reduce the probability of occurrence of misplaced filter linings: the manufacturer of the filter carried out a machine retrofit in the period 09/2022.This measure resulted in an improved quality of the raw nonwoven, which significantly reduces the detachment / slipping of the cover nonwoven.The supplier checked, changed and adjusted the settings on their internal machines, especially the monitoring system, in order to improve the ejection of faulty parts.As the error of a slipping filter cannot be completely ruled out after the above measures, the supplier is currently working on an improved camera system.This project is already at an advanced stage.
Event or Problem Description
The customer complained that the filter-lining of the microgard filter is misplaced.This was noticed during an incoming inspection.There was no indication that defective filters were used for patient measurements.

• Brand Name: MICROGARD II BACT/VIRAL FILTER
• Common Device Name: FILTER, BACTERIAL, BREATHING-CIRCUIT
• Manufacturer (Section D): VYAIRE MEDICAL GMBH; leibnizstrasse 7; hoechberg 97204 ; GM 97204
• Manufacturer (Section G): RIENSCH & HELD GMBH & CO. KG; hans-duncker-str. 1; hamburg 21035 ; GM 21035
• Manufacturer Contact: maren wiese ; leibnizstrasse 7; hoechberg 97204 ; GM 97204
• MDR Report Key: 19592379
• Report Number: 9615102-2024-00150
• Device Sequence Number: 12864378
• Product Code: CAH
• UDI-Device Identifier: 14250892903115
• UDI-Public: (01)14250892903115
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K111408
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MICROGARD II BACT/VIRAL FILTER
• Device Catalogue Number: V-892383
• Device Lot Number: RH221378
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2024
• Supplement Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 06/24/2024
• Supplement Report FDA Received Date: 09/25/2024
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown