MAUDE Adverse Event Report: VECTURA GROUP LIMITED BREELIB INHALATION SYSTEM

Model Number BREELIB STARTER PACK LAT1

Device Problem Failure to Deliver (2338)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

This report was identified as a missed report to fda, during inspection readiness review of safety data and is subsequently being submitted as late.The suspect device in this report, breelib is not 510k cleared.This case is being submitted to the fda as 'breelib' is a similar medical device to the 510k cleared fox mobile device.

Event Description

The incident was reported to the manufacturer (vectura) from bayer, with ref no.Cl-bayer-2021a238888 on 01 nov 21 concerning breelib inhalation system.This case report from chile concerns a patient (age and gender unknown) with pulmonary arterial hypertension (pah) who experienced 'general physical health deterioration' and was hospitalized (reported as deteriorating hospitalized patient).Bayer and vectura have a co-partner relationship where the breelib medical device is supplied to patients to use with ventavis (iloprost) therapy for pah in eu and latin american markets.The patient, who is enrolled in a patient support program, started receiving ventavis (iloprost) therapy (dose and frequency unknown) with the breelib inhalation system for the treatment of her pah on an unknown date.The reporter (bayer's patient support program via complaints process) commented: "the patient reported that breelib works perfectly for the first 10 to 12 days.After this number of days, breelib starts to work badly.It stops administering the right dose of medicinal product, even when the sterilization recommendations given on receiving the device are followed." details of patient identifiers, medical history, concurrent conditions and concomitant medications was not provided.It is unclear if the patient was in hospital prior to experiencing the device issues, or if an exacerbation of their pah (or any other concurrent condition) led to patient's hospitalization.It requires investigation on whether the device delivered the correct dose and confirmation on whether any doses were missed due to the reported issues.'general physical health deterioration' is an unlisted event according to the ventavis® smpc and the breelib instructions for use (ifu).Vectura considers the event of 'general physical health deterioration' as most likely related to progression of the patient's pah (or another concurrent condition), however, due to the lack of information and the reported device issues a conservative approach is being taken and the incident is being submitted.No further information has been received on this case and two unsuccessful follow up attempts were performed by bayer.The device in question was requested but it was not received and thus the quality investigation was completed based on historical data analysis and production records.Quality investigation suggests that the nebuliser head could be faulty, thereby potentially impacting on the intended performance of the device.In such a scenario, some likely causes of nebuliser head faults include: using the nebuliser head beyond its one-month lifetime.But as reported in this case the patient used it for 10-12 days.The nebuliser head not being washed or effectively cleaned, leading to damaged device.Breelib¿ ifu states that the components of breelib¿ must be cleaned in distilled water after each treatment and sterilized at least once a week.Inadequate cleaning may lead to clogging of the membrane and inadequate delivery rate of the medication.The nebuliser head becoming defective after release, root cause unconfirmed but may be due to manufacturing process issues.Device history record was reviewed by the quality devices team.All units passed the functional tests before release to the market.Based on the worst-case scenario, the investigation concluded that the alleged device fault reported could be due to a nebuliser head fault', but a full investigation of the actual device would be required to confirm or refute this position.

• Brand Name: BREELIB INHALATION SYSTEM
• Type of Device: BREELIB
• Manufacturer (Section D): VECTURA GROUP LIMITED; one prospect west; chippenham, SN14 6FH; UK SN14 6FH
• Manufacturer Contact: one prospect west; chippenham, SN14 -6FH
• MDR Report Key: 16435700
• MDR Text Key: 310157523
• Report Number: 3008702754-2023-04095
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: K142059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/24/2023

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: BREELIB STARTER PACK LAT1
• Device Catalogue Number: 08CD1046
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/01/2021
• Initial Date FDA Received: 02/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization