MAUDE Adverse Event Report: AEROGEN LIMITED AEROGEN SOLO CONTINUOUS NEBULIZATION SYRINGE; CNTS

Model Number AG-AS3085

Device Problems Crack (1135); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Material Integrity Problem (2978)

Patient Problem Cardiac Arrest (1762)

Event Date 10/04/2017

Event Type  Injury  

Manufacturer Narrative

Device used on a patient was not returned for evaluation.Device of the same lot has been returned by the user facility.It will undergo the evaluation.

Event Description

Initial complaint details are as follows: "per conversation with karen good,patient was receiving a continuous treatment of flolan.The aerogen solo continuous nebulization syringe (lot #hm16039) had a crack at the top of the barrel, near the plunger.They did not notice the crack, the medication leaked out of the syringe within 30 minutes.Due to the stoppage of nebulized medication, the patient coded, went into cardiac arrest.The patient was given cpr and another aerogen syringe was used to deliver flolan, the patient survived.Per karen this event will be reviewed by an internal team at the hospital.Karen is sending back the syringe, replacement syringe will be sent".Subsequent follow up on initial complaint details: it was confirmed, that the visual check was performed on the syringe prior to use, and a small crack was noted; "the original syringe had very fine crack that was difficult to see, if you weren't looking for it".

Manufacturer Narrative

1) the following additional information is added in the relevant sections throughout this report: 1.Addition of an evaluation summary for the devices of the same lot 2.Event problem and evaluation codes are added as per below: (b)(4).2) conclusion: firstly, the device used on a patient was not returned to aerogen ltd due to the suspicion of potential contamination.Therefore actual device evaluation was not performed.Instead devices of the same lot were subjected to the evaluation.(evaluation summary is enclosed as part of this report).Upon completion of the testing, failure mode and root cause of the reported cnts syringe crack could not be determined.At this time aerogen is confident that there is no issue relating to cracking of the cnts syringe.Secondly, description of the event references the use of flolan (epoprostenol sodium) drug for inhalation.According to the fda drug database: fda approved drug products - flolan (epoprostenol sodium) is delivered via injection route.Therefore it is not a drug approved for inhalation and therefore its use falls outside the scope of the intended use of the aerogen solo nebuliser.[aerogen solo nebuliser is intended for hospital use to nebulise physician-prescribed medications for inhalation which are approved for use with a general purpose nebuliser].Due to the fact that the use of epoprostenol is not covered within the intended use of the aerogen solo system, aerogen does not have any data associated with the performance characteristics of the device in this application, as well as this application is not addressed in aerogen's risk management processes.Therefore when the device is being used outside of its intended use the device may not function as intended; hence it is being used at the users risk.Thirdly, instruction for use (p/n 30-593) clearly states "do not use if there are signs of cracks, damage or foreign matter".According to the complaint details, the syringe was observed and a small crack was notes; the device was nonetheless used.Based on the above, aerogen ltd confirm the initially identified scope of the mdr being an adverse event.From the information retrieved out if the testing evaluation, there is no evidence to suggest that device malfunction also occurred in this instance.Should this become available at a later date, this complaint will be re-opened and updated accordingly and another follow up mdr will be submitted to the fda, if deemed relevant.At this time,this failure will continue to be monitored for any developing trends.

Event Description

According to mnf report # 3003399703-2017-00002, submitted on the 2nd november 2017, the following complaint details were provided: "per conversation with (b)(6), patient was receiving a continous treatment of flolan.The aerogen solo continuous nebulization syringe (lot # hm16039) had a crack at the top of the barrel, near plunger.They did not notice the crack, the medication leaked out of the syringe within 30 minutes.Due to the stoppage of nebulized medication, the patient coded, went to cardiac arrest.The patient was given cpr and another aerogen syringe was used to deliver flolan, the patient survived.Per (b)(6) this event will be reviewed by an internal team at the hospital.(b)(6) is sending back the syringe, replacement syringe will be sent".Subsequent follow up on initial complaint details: it was confirmed, that the visual check was performed on the syringe prior to use, and a small crack was noted; "the original syringe had very fine crack that was difficult to see, if you weren't looking for it".

• Brand Name: AEROGEN SOLO CONTINUOUS NEBULIZATION SYRINGE
• Type of Device: CNTS
• Manufacturer (Section D): AEROGEN LIMITED; galway business park; dangan; galway, H91HE 94; EI H91HE94
• MDR Report Key: 6996473
• MDR Text Key: 90881657
• Report Number: 3003399703-2017-00002
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• PMA/PMN Number: K103635
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: AG-AS3085
• Device Catalogue Number: AG-AS3085
• Device Lot Number: HM16039
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/05/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Weight: 156