MAUDE Adverse Event Report: VYAIRE MEDICAL GMBH VYAIRE; FILTER, BACTERIAL, BREATHING-CIRCUIT

Model Number V-892380

Device Problem Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/02/2023

Event Type  malfunction  

Event Description

It was reported to vyaire that the customer (b)(6) gmbh received a delivery from vyaire with two microgard filters that were incomplete.It was stated that the filter inlay was missing for one filter, and the other was missing 1/2 of the filter housing.The filters were identified and returned to vyaire for analysis.The filters were returned inside their original & sealed packaging; there is no indication that incomplete filters were used for patient measurements.

Manufacturer Narrative

This report is submitted with delay because the incident happened in germany and is not reportable in the eu but in the united states.The reportability in the us has initially been overlooked.The device has been returned to the manufacturer for evaluation.It has been confirmed that the filter inlay was missing in one of the microgard filters.This information was forwarded to the supplier (b)(4) gmbh & co.Kg.No reportable adverse event happened as there was no patient involvement.A clinical risk assessment was requested and 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 supplier (b)(4) 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 (b)(4) gmbh & co.Kg.Corrective and preventive actions were implemented by the supplier on 01/26/2022.The affected filter was produced before the implementation date.All other production lines produced microgard filters within specifications.

• Brand Name: VYAIRE
• Type of Device: 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: 18008557
• MDR Text Key: 326852983
• Report Number: 9615102-2023-00143
• Device Sequence Number: 1
• Product Code: CAH
• UDI-Device Identifier: 14250892903115
• UDI-Public: (01)14250892903115(11)211223
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K111408
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: V-892380
• Device Catalogue Number: V-892380
• Device Lot Number: RH 211786-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2023
• Date Manufacturer Received: 03/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/23/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other