MAUDE Adverse Event Report: AEROGEN, LTD. /EMERGO GROUP, INC. AERONEB PRO; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number CONTROL MODULE AG-AP1050-US

Device Problems Improper or Incorrect Procedure or Method (2017); Manufacturing, Packaging or Shipping Problem (2975); Application Program Problem: Medication Error (3198)

Patient Problems Respiratory Distress (2045); Therapeutic Response, Decreased (2271)

Event Date 01/16/2015

Event Type  malfunction  

Event Description

A pediatric patient was hospitalized with acute respiratory failure.The respiratory therapist (rt) immediately placed him on a high flow nasal cannula and gave him albuterol.Staff knew he would need continuous albuterol so they set up the continuous albuterol through the high flow system using the aerogen aeroneb pro nebulizer system.The patient began to improve, but within the hour, he began to decline and rt was about to give him some magnesium and call to admit him to the picu.The patient was in severe distress and began to be confused, his color worsened, etc.The rt then realized he was using the wrong power pack.The power pack that is the center of this problem has two buttons on the face of the unit.Essentially, this life saving medication shut off at 30 minutes or so, instead of continuing as we thought it had and the patient got very ill.It is important to know that there are two different power packs from the manufacturer, both of which are used in the rt department.The two types of power packs are defined as one that has two options (15 and 30 minutes, the aeroneb pro) and the second one has two options (30 minutes and continuous, the aeroneb pro-x).The unit that was involved with this error was the type that did not have the continuous option.The rt assumed he had the continuous unit and pushed the button where the normal continuous button was located, only this time it was the 30 minute option.The rt failed to read the descriptions located on each button.These two different devices look very similar, thus the reason for the error on the part of the rt.This was a rather stressful situation so the rt was not paying as much attention as he should have.The rt found the correct battery pack and restarted the albuterol.The patient improved.The suggestion is the manufacturer change the look of the two devices so mistakes can't happen.

• Brand Name: AERONEB PRO
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): AEROGEN, LTD. /EMERGO GROUP, INC.; 816 congress avenue suite 140; austin TX 78701
• MDR Report Key: 4500828
• MDR Text Key: 5352563
• Report Number: 4500828
• Device Sequence Number: 1
• Product Code: CAF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Invalid Data
• Type of Report: Initial
• Report Date: 02/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: CONTROL MODULE AG-AP1050-US
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/04/2015
• Event Location: Hospital
• Date Report to Manufacturer: 02/10/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/04/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES
• Patient Age: 8 YR