MAUDE Adverse Event Report: AEROGEN LTD AEROGEN PROFESSIONAL NEBULIZER SYSTEM

Device Problem Insufficient Information (3190)

Patient Problem Pulmonary Hypertension (4460)

Event Date 10/01/2020

Event Type  Injury  

Manufacturer Narrative

The aerogen pro-x controller (with the serial number (b)(4)) is mentioned within section 4 suspect medical device of the fda medwatch form filed by the user facility.However, upon further communication with the initial reporter ((b)(4)), it transpired that aerogen pro-x controller did not malfunction rather there was no connectivity between the cable and the pro-x controller.Upon replacement of the cable, continuous nebulisation resumed.The pro-x controller continued to be used during the procedure while the cable was disposed of and not available to be returned for the further investigation.The investigation of the complaint ((b)(4)) is due for closure by the (b)(6) 2021.However taking into account that (b)(4) general hospital has confirmed (via email communication) that cable is not available for the return and the lot number is not available either, while the controller has not malfunctioned and was back in use, the investigation is preliminary set to close as a non-return complaint with 'no fault found' being a root cause.The event description refers to the numerous complaints being made by the (b)(4) general hospital between (b)(6) 2018 and (b)(6) 2020.There were 5 complaints received within this timeframe ((b)(4)).Neither of these complaints were determined to be reportable and were closed with the cause being 'no fault found'.In addition to the above, the hospital reported a product problem in that aerogen pro-x controller does not include an audible alarm to inform of the instances when the cable is not communicating with the controller.As specified above, the cable was disposed of; hence investigation of the cable cannot be carried out; and, with regard to the alarm issue, an audible alarm is currently not a feature of the controller.Description of the event references the use of epoprostenol drug for inhalation.According to the fda drug database: fda approved drug products - epoprostenol 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.Hence use of the epoprostenol constitutes a user error, i.E., the device was used off-label.Based on the fact that 'other serious' injury was reported, aerogen determined that the occurred event is an mdr reportable adverse event.Due to the fact that the device is not available to be returned for investigation, it can be ascertained that investigation is due to be closed as a non-return and no further conclusions can be drawn regarding the root cause of the event.Should the aforementioned preposition change by the time the complaint is officially closed, the new and/or additional information will be submitted to the fda if deemed necessary.

Event Description

Upon arrival into icu patient's room, the aerosol medication administration was not running.The yellow light was showing on the aerogen pro-x controller.Six cc of the aerosol medication were removed from the solo cup.The infusion pump was running at approximately 4 cc per hour.Thus, the aerosol medication was not running for at least 1.5 hours.Patient's pa pressure noted to be in high 60's.Approximately 1 hour later the patient's pa pressure was in the 30's.We had multiple issues arising from (b)(6) 2018 through (b)(6) 2020.Some of these issues were addressed but we continue to request an audible alarm from the manufacturer.When the controller senses that the cable is not communicating, a bright yellow light turns on.There is no complimentary audible alarm.Many times, an rrtor rn will not notice this light until the patient begins to clinically decompensate.Upon trouble shooting and system check, the clinician finds that the nebulizer cup full.(the infusion pump continues to administer the med, yet the nebulizer has stopped working because there is no cable communication with the controller).We have also been told repeatedly by the company that this would be a huge endeavor to have approved by the fda, but we have not received any updates of information regarding whether they will create this alarm to avoid future disruption of continuous nebulized medications.

• Brand Name: AEROGEN PROFESSIONAL NEBULIZER SYSTEM
• Type of Device: NEBULIZER
• Manufacturer (Section D): AEROGEN LTD; galway business park; dangan; galway H91 H
• Manufacturer (Section G): AEROGEN LIMITED; galway business park; dangan; galway
• Manufacturer Contact: iryna barouskaya ; galway business park; dangan; galway H91 H ; 0035391540
• MDR Report Key: 11064004
• MDR Text Key: 229292700
• Report Number: 3003399703-2020-00001
• 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: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR
• Patient Weight: 102