MAUDE Adverse Event Report: AEROGEN LTD AEROGEN SOLO ADULT T-PIECE 22MM; AEROGEN SOLO T-PIECE

Model Number AG-AS3010

Device Problem Use of Device Problem (1670)

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

Event Date 12/20/2023

Event Type  Injury  

Event Description

An intubated and ventilated patient had an aerogen device connected to the ventilator tubing, when all of the sudden there was a leak on the ventilator and when this was investigated by the bedside nurse it was note that the t-piece was cracked.This was replaced immediately, no harm caused to patient.The customer stated they use maquet servo u ventilators and the t piece was used with the anaconda device.Flolan was initially started on (b)(6) 2023 at 0100 am at 50 ng/kg/min and was continuously running for 11 hours at this concentration.Flolan was discontinued on (b)(6) at 1200.Isoflurane was started on (b)(6) @1100am and continuously delivered until (b)(6).The isoflorane rate was between 4 to 10 ml/hour.Isoflorane was used when the t piece cracked.T piece was in use for 4 days.Based on our protocol, we only have to change the t piece every 7 days.Flolan and isoflorane were not running simultaneously.The t piece was connected to patient's ventilator circuit while patient was receiving isoflorane.Aerogens complaint team are in continued follow up with the initial reported for additional information on the event and requested the device be returned to aerogen for investigation.

Manufacturer Narrative

Aerogen have taken the appropriate measures to review and investigate the complaint received.Aerogen have requested further information from the reporting healthcare worker to determine further details on the event and had requested the return of the device.A review per aerogen's 'field correction/removal procedure' was completed based on this complaint received which may pose a risk to patients.Based on the nature of the complaint, and current investigation in progress it has been concluded that no field correction or removal is required by aerogen at this time.This will be reviewed as investigation progresses and if any further information becomes available to aerogen which may impact the previous no fsca determination, the review and conclusion will be documented within the subsequent report.

Manufacturer Narrative

Aerogen have taken the appropriate measures to review and investigate the complaint received.Aerogen have requested further information from the reporting healthcare worker to determine further details on the event and had requested the return of the device.A review per aerogen's 'field correction/removal procedure' was completed based on this complaint received which may pose a risk to patients.Based on the the nature of the complaint, and current investigation in progress it has been concluded that no field correction or removal is required by aerogen at this time.This will be reviewed as investigation progresses and if anyfurther information becomes available to aerogen which may impact the previous no fsca determination, the review and conclusion will be documented within the subsequent report.Update on 16th of april 2024: follow-up 1 submitted for additional information of investigation conclusions completeed.The report has been updated for the following fields only: b4, g6, h2, h6, h10 and narrative below: risk assessment: aerogen ltd risk management documentation, identifies has identified the risk of "loss of anaesthesia/sedation" as the resultant patient harm from reduced anaesthetic delivery to patient due to a leakage of anaesthetic from the breathing circuit through cracks in the nebuliser or t-piece.The aerogen solo system instruction for use (ifu) (p/n 30-354 rev u, page 5), state that the aerogen solo adult t-piece may be used with anaesthetic ventilators with specified volatile anaesthetic agents (isoflurane, sevoflurane, desflurane) under the stated conditions in the ifu which have been validated by aerogen.In the reported incident, the aerogen solo t-piece cracked after 4 days of exposure, and it was not stated what percentage of isoflurane anaesthetic was used at this time.This exposure time exceeds aerogen's recommended exposure period of 12 hours, as outlined in the aerogen solo system ifu.In addition, off label drug flolan was used for 11 hours before the patient was switched to isoflurane.This can be defined as abnormal use, as the aerogen solo system is being used outside of the intended use as specified in the ifu.The available evidence indicates that no serious harm/injury or impact to the patient serious occurred.The aerogen solo t-piece exposure to isoflurane exceeded the ecommended time period of 12 hours and was also used with the off-label drug.Therefore, the reported device issue can be attributed to abnormal use.Clinical assessment: there was no patient impact/harm reported as a result of this incident.Based on the information provided, the described events relate to the use of the aerogen solo adult t-piece (22mm) in combination with an sedaconda system.In line with the aerogen solo system instruction for use (ifu) (p/n 30-354 rev u, page 5), the aerogen solo adult t-piece may be used with anaesthetic ventilators with specified volatile anaesthetic agents (isoflurane, sevoflurane, desflurane) under the stated conditions in the ifu which have been validated by aerogen.To aerogen's knowledge, the sedaconda system is not an anaesthetic ventilator.Rather, it is an anaesthetic conserving device that allows delivery of volatile anaesthetic agents into a circuit and also acts as a modified heat and moisture exchanger.As detailed within the aerogen solo system ifu (p/n 30-354 rev u, page 5), use of the aerogen solo and t-piece during the administration of volatile anaesthetics may result in adverse effects on the constituent plastics.Aerogen have determined that, using anaesthetic ventilators, isoflurane 3.5%, sevoflurane 8% and desflurane 10% are compatible, with a maximum duration of exposure of 12 hours.It is advised not to use with volatile anaesthetics unless known to be compatible.In the current incident, it was reported that the aerogen solo t-piece cracked after 4 days of exposure.It is unclear what percentage of anaesthetic was used based on the available evidence.Conclusion the device involved in the reported complaint has not been returned to aerogen and has been discarded.Cracks on plastic of system adapter due to user misuse.Based on the information specified, the use of the aerogen solo adult t-piece with the sedaconda system is abnormal use, as the aerogen solo system is being used outside of its intended use.The aerogen solo t-piece duration of exposure to isoflurane exceeded the recommended period of 12 hours, as outlined in the aerogen solo system ifu.This is abnormal use, as the aerogen solo system is being used outside of its intended use.

Event Description

An intubated and ventilated patient had an aerogen device connected to the ventilator tubing, when all of the sudden there was a leak on the ventilator and when this was investigated by the bedside nurse it was note that the t-piece was cracked.This wasreplaced immediately, no harm caused to patient.The customer stated they use maquet servo u ventilators and the t piece was used with the anaconda device.Flolan was initially started on (b)(6) 2023 at 0100 am at 50 ng/kg/min and was continuously running for 11 hours at this concentration.Flolan was discontinued on (b)(6) at 1200.Isoflurane was started on (b)(6) @1100am and continuously delivered until (b)(6).The isoflorane rate was between 4 to 10 ml/hour.Isoflorane was used when the t piece cracked.T piece was in use for 4 days.Based on our protocol, we only have to change the t piece every 7 days.Flolan and isoflorane were not running simultaneously.The t piece was connected to patient's ventilator circuit while patient was receiving isoflorane.Aerogens complaint team are in continued follow up with the initial reported for additional information on the event and requested the device be returned to aerogen for investigation.

• Brand Name: AEROGEN SOLO ADULT T-PIECE 22MM
• Type of Device: AEROGEN SOLO T-PIECE
• Manufacturer (Section D): AEROGEN LTD; galway business park; dangan; galway, H91EH 6C; EI H91EH6C
• Manufacturer (Section G): AEROGEN LTD.; galway business park; dangan; galway, H91EH 6C; EI H91EH6C
• Manufacturer Contact: desmond monaghan ; galway business park; dangan; galway, H91EH-6C ; EI H91EH6C
• MDR Report Key: 18541155
• MDR Text Key: 333195347
• Report Number: 3003399703-2024-22138
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AG-AS3010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other