MAUDE Adverse Event Report: CAREFUSION, INC ETCO2 CANNULA 7', ADULT, MALE; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Catalog Number 2812M-10

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Hypoxia (1918)

Event Date 02/07/2017

Event Type  Injury  

Manufacturer Narrative

Initial emdr submission.Customer confirmed that no sample and no lot number is available.If any additional information becomes available a follow up submission will be filed.(b)(4).

Event Description

During the gi procedure, one side of the cannula measures co2 while the other side of the cannula delivers oxygen.There was an instance on a patient where the patient desaturated because the nasal cavity on one side was occluded by the patient's own anatomy and this side had the delivery of oxygen.Due to the patient's anatomy the patient desaturated since the other nostril that was patent was not receiving oxygen because the nasal prong on that side was for the co2 measurement and not oxygen delivery.No sample is available.The patient¿s oxygen saturation decreased below 50.The patient involved was put on an oxygen mask and the oxygen saturations then increased to 100% very quickly.There was no lasting harm to the patient.Lot number is unknown.".

• Brand Name: ETCO2 CANNULA 7', ADULT, MALE
• Type of Device: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway dr; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION, INC; cerrada vía de la producción; no. 85., parque industrial mex; mexicali baja california norte ; MX
• Manufacturer Contact: jill rittorno ; 22745 savi ranch parkway; yorba linda, CA 92887
• MDR Report Key: 6345190
• MDR Text Key: 67822819
• Report Number: 8030673-2017-00283
• Device Sequence Number: 1
• Product Code: CCK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120518
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 2812M-10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/07/2017
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention