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 07/22/2023

Event Type  Injury  

Event Description

Customer reported the 'nebuliser delivery system cracked and shattered'.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.

Event Description

Customer reported the 'nebuliser delivery system cracked and shattered'.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 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.Update on the 23rd of october: follow up report 1 submitted for the addtiional information of investigation conclusions completed.The report has been updated for the following fields, b4,d4, g6,h2,h6, h8 and h10 and narrative below: the device was not returned for investigation.Risk assessment: analysis of aerogens risk documentation, 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" at the time of the event, the anaconda system was being used to deliver isoflurane, a volatile anaesthetic in combination with the aerogen solo adult t-piece (22mm) and the aerogen solo nebuliser.To aerogen's knowledge, the anaconda system is not an anaesthetic ventilator, rather it acts as a modified heat and moisture exchanger which allows delivery of volatile anaesthetic agents into a circuit.It was stated that the t-piece had shattered after approximately 7-8 hours use with isoflurane and anaconda system on a ventilator circuit.The aerogen solo nebuliser was being used to deliver ventolin but was not nebulising at the time of the reported incident.As detailed within the aerogen solo system ifu, 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 reported incident, the aerogen solo t-piece cracked after approximately 7-8 hours of exposure.Although this exposure time does not exceed aerogen's recommended exposure period of 12 hours, as outlined in the aerogen solo system ifu, it is unclear what the percentage of anaesthetic was utilised at the time of the incident.This incident 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 in the incident report, the described event relates to the use of the aerogen solo adult t piece (22mm) in combination with an anaconda system made by sedana medical.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 anesthetic ventilators with specified volatile anesthetic agents (isoflurane, sevoflurane, desflurane) under the stated conditions in the ifu which have been validated by aerogen.To aerogen's knowledge, the anaconda system is not an anesthetic ventilator.Rather, it is an anesthetic conserving device that allows delivery of volatile anesthetic agents into a circuit and also acts as a modified heat and moisture exchanger.Aerogen have determined that, using anesthetic 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 anesthetics unless known to be compatible.Although isoflurane was delivered for approximately 7-8 hours in the current incident, it is unclear what percentage of anesthetic was used.The available evidence indicates that no patient serious injury/death occurred, and a reported device problem was identified to be attributable to abnormal use.Conclusion: the device involved in the reported complaint has not been returned to aerogen and has been discarded.As part of the investigation into this event, risk and clinical assessment were completed.To aerogen's knowledge, the anaconda system is not an anaesthetic ventilator, rather it acts as a modified heat and moisture exchanger which allows delivery of volatile anaesthetic agents into a circuit and therefore the use if this device is considered abnormal use.This event therefore is attributed to abnormal use of the device by the user.

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.Update on the 23rd of october: follow up report 1 submitted for the additional information of investigation conclusions completed.The report has been updated for the following fields, b4,d4, g6,h2,h6, h8 and h10 and narrative below: the device was not returned for investigation.Risk assessment: analysis of aerogens risk documentation, 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." at the time of the event, the anaconda system was being used to deliver isoflurane, a volatile anaesthetic in combination with the aerogen solo adult t-piece (22mm) and the aerogen solo nebuliser.To aerogen's knowledge, the anaconda system is not an anaesthetic ventilator, rather it acts as a modified heat and moisture exchanger which allows delivery of volatile anaesthetic agents into a circuit.It was stated that the t-piece had shattered after approximately 7-8 hours use with isoflurane and anaconda system on a ventilator circuit.The aerogen solo nebuliser was being used to deliver ventolin but was not nebulising at the time of the reported incident.As detailed within the aerogen solo system ifu, 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 reported incident, the aerogen solo t-piece cracked after approximately 7-8 hours of exposure.Although this exposure time does not exceed aerogen's recommended exposure period of 12 hours, as outlined in the aerogen solo system ifu, it is unclear what the percentage of anaesthetic was utilised at the time of the incident.This incident 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 in the incident report, the described event relates to the use of the aerogen solo adult t piece (22mm) in combination with an anaconda system made by sedana medical.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 anesthetic ventilators with specified volatile anesthetic agents (isoflurane, sevoflurane, desflurane) under the stated conditions in the ifu which have been validated by aerogen.To aerogen's knowledge, the anaconda system is not an anesthetic ventilator.Rather, it is an anesthetic conserving device that allows delivery of volatile anesthetic agents into a circuit and also acts as a modified heat and moisture exchanger.Aerogen have determined that, using anesthetic 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 anesthetics unless known to be compatible.Although isoflurane was delivered for approximately 7-8 hours in the current incident, it is unclear what percentage of anesthetic was used.The available evidence indicates that no patient serious injury/death occurred, and a reported device problem was identified to be attributable to abnormal use.Conclusion: the device involved in the reported complaint has not been returned to aerogen and has been discarded.As part of the investigation into this event, risk and clinical assessment were completed.To aerogen's knowledge, the anaconda system is not an anaesthetic ventilator, rather it acts as a modified heat and moisture exchanger which allows delivery of volatile anaesthetic agents into a circuit and therefore the use if this device is considered abnormal use.This event therefore is attributed to abnormal use of the device by the user.Update on the 12th of january: follow up report 2 submitted for the addition of 510k number.The report has been updated for the following fields, b4,g4, g6,h2.

Event Description

Customer reported the 'nebuliser delivery system cracked and shattered'.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; city, H91EH 6C; EI H91EH6C
• Manufacturer Contact: andrea small ; galway business park; dangan; galway ; 3539154040
• MDR Report Key: 17564505
• MDR Text Key: 321341104
• Report Number: 3003399703-2023-21809
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: AG-AS3010
• Device Lot Number: 234792453
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other