MAUDE Adverse Event Report: CAREFUSION P/N 9320 LOW FLOW AIR/OXYGEN MICROBLENDER; MIXER, BREATHING GASES, ANESTHESIA INHALATION

Model Number MICROBLENDER

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Low Oxygen Saturation (2477)

Event Date 10/06/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).In the event the device is received for evaluation or additional information is received a follow-up report will be submitted.At this time, carefusion has not received the device from the customer.(b)(4).

Event Description

Carefusion received a user facility medwatch in which the customer stated that intubation was attempted three times due to the infant crying.The infant de-saturated between attempts to mid 50's on blender oxygen via positive pressure ventilation.The t-piece was changed as there was concern it was not working correctly.The pulse oximeter was moved to the arm.The infant was put on the ventilator at 100% and the saturations were 98-100%.When intubation was attempted, the patient de-saturated to the low 60's.

Manufacturer Narrative

The customer stated that the device has been repaired and placed back in to service and that no components are being returned therefore an investigation cannot be completed.In the event additional information is received then a follow-up report will be submitted at that time.

• Brand Name: P/N 9320 LOW FLOW AIR/OXYGEN MICROBLENDER
• Type of Device: MIXER, BREATHING GASES, ANESTHESIA INHALATION
• Manufacturer (Section D): CAREFUSION; 22745 savi ranch parkway; yorba linda CA 92887
• Manufacturer (Section G): CAREFUSION; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: jill rittorno ; 22745 savi ranch pkwy; yorba linda, CA 92887 ; 7149227830
• MDR Report Key: 5356015
• MDR Text Key: 35530472
• Report Number: 2021710-2016-02657
• Device Sequence Number: 1
• Product Code: BZR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K883038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MICROBLENDER
• Device Catalogue Number: 03920A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/17/2015
• Initial Date FDA Received: 01/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 1 DA
• Patient Weight: 6