MAUDE Adverse Event Report: VECTURA GROUP LIMITED AKITA® JET INHALATION SYSTEM; AKITA JET

Catalog Number 01HP0100

Device Problems Insufficient Flow or Under Infusion (2182); Improper Flow or Infusion (2954); Pressure Problem (3012)

Patient Problem Pneumothorax (2012)

Event Date 09/15/2021

Event Type  Injury  

Event Description

The incident was reported to the manufacturer from its distributor in switzerland.This case report concerns a 17-year old female patient from serbia with cystic fibrosis (cf) who was hospitalised due to a pneumothorax.The device was reported to show an error of [?] pressure not stable' for a few days prior to the event.On (b)(6) 2021, the patient's father reported the patient was in hospital due to a pneumothorax.It was reported that the akita jet inhalation system showed that the 'pressure was not stable' on the display after each breath for a few days prior to the event.No action was taken by the patient's carer in response to the error messages.The carer did not connect the pressure error messages with the beginning of a pneumothorax/ pneumothorax exacerbation event.It was reported that the patient was in poor health and had already been hospitalised 5 times during the year.The akita jet was used for inhalation of nacl and dnase for the treatment of cf, as prescribed by her physician in (b)(6).The patient was also receiving autogenic drainage therapy and colistin for her cf.Approximately 10 days prior to noticing error messages on the device the patient had experienced upper chest pain.The patient's breath became a little shorter 5 hours after inhalation.The device was imported into serbia from relatives who live in switzerland.The device has been requested for investigation.A replacement device has been provided by the distributor.Details of the akita jet display error message and symptoms at the time of the event were not reported.The patient was hospitalised due to a pneumothorax, details of the hospital treatment for the event were not provided.The current condition of the patient is unknown.Pneumothorax is a recognised complication of cystic fibrosis, reflecting a weakening of the pleural surface by underlying inflammation and sepsis, coupled with the increased mechanical stress on the pleura in obstructive lung disease.In this case, the pressure error message displayed on the akita jet device was disregarded and the patient continued to use the device for a few days.The manufacturer considers it is highly unlikely that the akita jet could cause a pneumothorax.The pressures required to do this would have been greater than the patient could withstand whilst maintaining a seal on the mouthpiece.Where a patient has an existing pneumothorax (which may be common in cf patients with compromised lungs), it is possible that continued use of the akita jet may exacerbate the condition.The patient was experiencing symptoms of chest pain prior to error messages on the device.The precise error has not been reported.The device provides an error and stops a breath early for any extreme overpressure in the inhalation phase.Therefore, it is probable that this case represents an event caused by the patient's conditions and protection against a fault functioned correctly.The manufacturer considers the event of pneumothorax, as an unexpected event according to the akita jet instructions for use (ifu) and unlikely related to pressure in the device (pending device investigation).The device risk assessment includes the risks associated with airflow and pressure.Too low pressure leading to harms of inadequate drug disposition or no nebulization (due to compressor failure).

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.This report mirrors the initial submission to eu competent authorities.A fu report is also being submitted, which downgrades the case to non-reportable.

Event Description

The incident was reported to the manufacturer from its distributor in switzerland.This case report concerns a 17-year old female patient from serbia with cystic fibrosis (cf) who was hospitalised due to a pneumothorax.The device was reported to show an error of pressure not stable' for a few days prior to the event.On (b)(6) 2021, the patient's father reported the patient was in hospital due to a pneumothorax.It was reported that the akita jet inhalation system (sn (b)(6)) showed that the 'pressure was not stable' on the display after each breath for a few days prior to the event.No action was taken by the patient's carer in response to the error messages.The carer did not connect the pressure error messages with the beginning of a pneumothorax/ pneumothorax exacerbation event.It was reported that the patient was in poor health and had already been hospitalised 5 times during the year.The akita jet was used for inhalation of nacl and dnase for the treatment of cf, as prescribed by her physician in belgrade.The patient was also receiving autogenic drainage therapy and colistin for her cf.Approximately 10 days prior to noticing error messages on the device the patient had experienced upper chest pain.The patient's breath became a little shorter 5 hours after inhalation.The device was imported into serbia from relatives who live in switzerland.Details of the akita jet display error message and symptoms at the time of the event were not reported.Note that the device sn was reported as sn (b)(6) in the initial submission, this has been corrected to (b)(6) in this final report as the actual device in use at the time of the event.Further follow up information stated that the patient was again hospitalised for pneumonia.It was reported that the patient's physician thinks that pneumonia and pneumothorax are related to untreated covid-19.The current condition of the patient is unknown.Pneumothorax is a recognised complication of cystic fibrosis, reflecting a weakening of the pleural surface by underlying inflammation and sepsis, coupled with the increased mechanical stress on the pleura in obstructive lung disease.In this case, the pressure error message displayed on the akita jet device was disregarded and the patient continued to use the device for a few days.The manufacturer considers it is highly unlikely that the akita jet could cause a pneumothorax.The pressures required to do this would have been greater than the patient could withstand whilst maintaining a seal on the mouthpiece.Where a patient has an existing pneumothorax (which may be common in cf patients with compromised lungs), it is possible that continued use of the akita jet may exacerbate the condition.The patient was experiencing symptoms of chest pain prior to error messages on the device.The precise error has not been reported.The device provides an error and stops a breath early for any extreme overpressure in the inhalation phase.Therefore, it is probable that this case represents an event caused by the patient's conditions and protection against a fault functioned correctly.Follow up information received by the manufacturer included that the patient was again hospitalised due to the event of pneumonia.The patient's physician stated that the events of pneumothorax and pneumonia are likely to be related to patient's underlying condition of untreated covid-19.

Manufacturer Narrative

This is a non-reportable incident as the event of pneumothorax was assessed as related to patient's underlying condition of covid-19 and not related to the device.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 device sn was reported as sn (b)(6) in the initial submission, this has been corrected to (b)(6) in this final report as the actual device in use at the time of the event.

• Brand Name: AKITA® JET INHALATION SYSTEM
• Type of Device: AKITA JET
• 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: 16426484
• MDR Text Key: 310100450
• Report Number: 3008702754-2023-00001
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K090730
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 01HP0100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2010
• 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: COLISTIN; COLISTIN; DNAASE; DNAASE; NACL; NACL
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 17 YR
• Patient Sex: Female