MAUDE Adverse Event Report: CAREFUSION 211, INC. DBA CAREFUSION AIRLIFE PREFILLED NEBULIZER KIT; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number 1000ML

Device Problems Failure to Deliver (2338); Defective Device (2588)

Patient Problems Anxiety (2328); Low Oxygen Saturation (2477)

Event Date 05/11/2016

Event Type  malfunction  

Event Description

The patient was on trach mask, for the first time today on the airlife nebulizer kit (trach mask set up).The device seemed to have a factory defect and stopped delivering oxygen to the patient, in which he desaturated to 82% and became agitated.I knew what had happened right away and placed him on the ventilator (at bedside) immediately and hyper-oxygenated him.I replaced the device and continued him on a new airlife nebulizer kit.I have seen this manufacturer defect on one of the devices before.

• Brand Name: AIRLIFE PREFILLED NEBULIZER KIT
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): CAREFUSION 211, INC. DBA CAREFUSION; 22745 savi ranch parkway; yorba linda CA 92887
• MDR Report Key: 5916966
• MDR Text Key: 53626378
• Report Number: 5916966
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1000ML
• Device Catalogue Number: CK0010
• Device Lot Number: Z1-1512262
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/17/2016
• Event Location: Hospital
• Date Report to Manufacturer: 08/17/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/31/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR