MAUDE Adverse Event Report: CAREFUSION LIMBO-O SINGLE LIMB ANESTHESIA CIRCUIT

Catalog Number AGNX204X

Device Problems Occlusion Within Device (1423); Device Operates Differently Than Expected (2913)

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

Event Date 05/17/2016

Event Type  malfunction  

Event Description

Anesthesiologist had intubated the patient but was having difficulty ventilating the patient.Switched to ambu bag and ventilated without difficulty.Switched out the anesthesia breathing circuit and ventilation ensued with ease.Initial breathing circuit inspected and found to have a clear plastic covering over the intake valve of the filter.

• Brand Name: LIMBO-O SINGLE LIMB ANESTHESIA CIRCUIT
• Type of Device: ANESTHESIA CIRCUIT
• Manufacturer (Section D): CAREFUSION; 22745 savi ranch parkway; yorba linda CA 92887
• MDR Report Key: 5719753
• MDR Text Key: 47203395
• Report Number: 5719753
• Device Sequence Number: 1
• Product Code: CAZ
• 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: 05/27/2016,06/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: AGNX204X
• Device Lot Number: 0000872490
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/27/2016
• Event Location: Hospital
• Date Report to Manufacturer: 05/27/2016
• 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 Age: 41 YR
• Patient Weight: 62