MAUDE Adverse Event Report: CAREFUSION LOW FLOW AIR/OXYGEN MICORBLENDER; MIXER, BREATHING GASES, ANESTHESIA INHALATION

Model Number MICROBLENDER

Device Problem Improper Device Output (2953)

Patient Problem Low Oxygen Saturation (2477)

Event Date 12/28/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The customer did not provide patient demographics such as age, date of birth, gender, and weight.Any additional information received from the customer will be included in a follow-up report.(b)(4).The carefusion factory repair technician was able to confirm the customer's reported allegation.The suspect device's knob is stuck at twenty-one percent.The carefusion factory repair technician replaced the affected components and performed testing.The unit is meeting service specifications.

Event Description

The customer reported while using the low flow air/oxygen micorblender; the fio2 (fraction of inspired oxygen) stays at twenty-one percent even dialed up to one-hundred percent.The issue occurred during patient use.The customer reported the patient was put on a high flow nasal cannula and desaturated.

Manufacturer Narrative

Results of investigation: the carefusion failure analysis laboratory received the suspect component for investigation.An investigation was performed and identified the root cause of the reported issue was due to bent stem valve.Upon further inspection under a microscope, the stem head was damaged.This issue will be internally investigated within carefusion.

• Brand Name: LOW FLOW AIR/OXYGEN MICORBLENDER
• 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: 5381529
• MDR Text Key: 36460398
• Report Number: 2021710-2016-02743
• 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: consumer,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/28/2015

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: 03803T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/28/2015
• Initial Date FDA Received: 01/20/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2010
• 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): Required Intervention