MAUDE Adverse Event Report: VECTURA GROUP LIMITED BREELIB INHALATION SYSTEM

Model Number BREELIB STARTER PACK LAT1

Device Problem Failure to Deliver (2338)

Patient Problems Cyanosis (1798); Dyspnea (1816); Fatigue (1849)

Event Date 03/13/2023

Event Type  Injury  

Manufacturer Narrative

The suspect device in this report, breelib is not 510k cleared for use in the us.This case is being submitted to the fda as 'breelib' is a similar medical device to the 510k cleared fox mobile device.Neither the fox mobile or breelib are currently distributed in the us.

Event Description

The incident was reported to the manufacturer (vectura) from bayer, with ref no.Co-bayer-(b)(4).On 24 mar 2023 concerning the breelib inhalation system.Bayer and vectura have a co-partner relationship where the breelib medical device (vectura) is supplied to patients to use with ventavis (iloprost) therapy (bayer) for pulmonary arterial hypertension (pah) in the eu and latin american markets.This case report from colombia concerns a 50 year-old female with pulmonary arterial hypertension (pah) who reports experiencing shortness of breath [dyspnoea], cyanosis [cyanosis] and tiredness [fatigue].The reporter suspects that the adverse events were caused by a missed dose of ventavis medication due to a failure of the breelib inhalation system [drug dose omission by device].Per the initial report received from bayer, the patient, who is enrolled in a patient support program, started receiving ventavis (iloprost) therapy (6 df, daily) for the treatment of her pah on 11 feb 2011.The patient started receiving ventavis (iloprost) therapy (dose and frequency unknown) using the breelib device on (b)(6) 2023.On (b)(6) 2023, 13 days after starting therapy using the breelib inhalation system, she experienced dyspnoea and cyanosis.An unknown time later she experienced fatigue.It was reported that the ventavis (iloprost) treatment was not changed as a result of the events, but it is unknown if the patient stopped using the breelib nebulizer.The events of dyspnoea and cyanosis were resolving at the time of this report.The reporter (bayer's patient support program via complaints process) considered the event of fatigue to be related to ventavis administration and cyanosis and dyspnoea to be related to the breelib nebulizer use.No causality assessment was received for ventavis with regards to dyspnoea or cyanosis nor for the breelib nebulizer with regards to fatigue.The patient refused consent to contact her healthcare professional for further information.Further details on the events, medical history, concomitant medications and clinical condition of the patient is unknown.It is unclear whether the patient's cyanosis was central or peripheral.Central cyanosis refers to inadequate cardiopulmonary function and a failure to fully oxygenate the blood passing from heart to lungs and back.This is a medically important event and is thus assessed as serious.Vectura considers central cyanosis to be the most likely scenario based on the patient's underlying condition of pah.There is no information on whether the patient was hospitalized or received any other medical intervention due to the events described in this case by the reporter.According to the epidemiological data for pah, the overall survival rate of patients is approximately 90% at 1 year and 50% at 5 years and further research is needed to establish whether pah therapies improve survival.The patients may experience worsening of pah, with just over 30% of clinical worsening being due to hospitalization and approximately 35% of hospitalization for pah patients is a pah-related event.Vectura considers the event of 'cyanosis, fatigue, dyspnoea' as most likely related to the progression of the patient's pah (or another concurrent condition), however, due to the lack of information and the reported device issue a conservative approach is being taken and the incident is being submitted.No further information has been received on this case after multiple follow-up attempts.The device in question has been discarded by the patient and is not available for investigation.A quality investigation was completed based on historical data analysis and production records.The investigation concluded that the most likely potential root cause(s) of the reported device malfunction was damaged base unit due to liquid ingress, likely from user error in cleaning of the device or exhaling into the device.Alternatively, the base unit is likely working as intended.Quality investigation to identify potential root cause(s) involved historical data analysis of complaints with similar descriptions concerning device related issues, and review of the device history record.It was noted from this activity that all units passed the functional tests before release to the market.A full investigation of the actual device would be required to confirm the device malfunction.At the time of this report, the compliant could not be confirmed.Breelib¿ is not designed for emergency and life support use.The breelib risk management file considers that a short delay in therapy (up to 24 hours) may result in temporary discomfort and chronic missed doses can result in injury or impairment which may require professional medical intervention.Ventavis® is administered using the breelib between 6- 9 times per day depending upon individual patient need and tolerability to ventavis®.Ventavis® is not first line therapy for pah, which is a progressive, incurable disease that will eventually lead to right heart failure and death.Ventavis® improves the clinical course of pah but can only delay disease progression.Ventavis® is unlikely to be used as a monotherapy for pah, although no details of concomitant medication have been provided for this case.The patient support program this patient is enrolled on, ensures the patient receives a replacement device within 24 hours should device issues be experienced, and this is taken into consideration in the risk file.Patients are issued with an additional reserve device, to use should they experience any issues with their primary device, supplemented by instructions to continue therapy and seek medical advice as and when appropriate.Breelib inhalation system is not 510k cleared.The report is being submitted to the us fda as the breelib device is a similar device to the 510k cleared fox mobile device.

• Brand Name: BREELIB INHALATION SYSTEM
• Type of Device: BREELIB
• Manufacturer (Section D): VECTURA GROUP LIMITED; one prospect west; chippenham, wiltshire SN14 6FH; UK SN14 6FH
• Manufacturer (Section G): VECTURA GROUP LIMITED; one prospect west; chippenham, wiltshire SN14 6FH; UK SN14 6FH
• Manufacturer Contact: sally du toit ; one prospect west; chippenham, wiltshire SN14 -6FH ; UK SN14 6FH
• MDR Report Key: 16792776
• MDR Text Key: 313802034
• Report Number: 3008702754-2023-05398
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K142059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 04/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2023
• 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
• Date Manufacturer Received: 03/24/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/21/2022
• 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
• Treatment: VENTAVIS NEBULISER SOLUTION, 6 DF, QD, INHALATION
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Sex: Female