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U.S. Department of Health and Human Services

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

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AEROGEN, LTD. /EMERGO GROUP, INC. AERONEB PRO; NEBULIZER (DIRECT PATIENT INTERFACE) Back to Search Results
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.
 
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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 Key4500828
MDR Text Key5352563
Report Number4500828
Device Sequence Number1
Product Code CAF
Reporter Country CodeUS
Number of Events Reported1
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 NumberCONTROL MODULE AG-AP1050-US
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/04/2015
Event Location Hospital
Date Report to Manufacturer02/10/2015
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/04/2015
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NO OTHER THERAPIES
Patient Age8 YR
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