MAUDE Adverse Event Report: CAREFUSION AIRLIFE

Model Number 2K8008

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

We have discovered unexpected fluid residing in 30-70% of the manual resuscitation bags (ambu bags) supplied by carefusion.This is, according to the manufacturer, benign lubricant.However, we are unable to independently determine the potential patient impact of this substance being forced into a patient's lungs.This is a product defect with unknown patient consequence.The volume of this substance is concerning because during use it can be unintentionally introduced into the alveolar space.We can find no evidence that this lubricant is safe should it be introduced into that area.

• Brand Name: AIRLIFE
• Type of Device: AIRLIFE
• Manufacturer (Section D): CAREFUSION
• MDR Report Key: 4604088
• MDR Text Key: 5698658
• Report Number: MW5041417
• Device Sequence Number: 1
• Product Code: BTM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 03/09/2015
• 6 Devices were Involved in the Event: 1 2 3 4 5 6

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2K8008
• Device Catalogue Number: 2K8008
• Device Lot Number: Y11B1050
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1