MAUDE Adverse Event Report: CAREFUSION, INC BIRD HIGH FLOW BLENDER SERIES; MIXER, BREATHING GASES, ANESTHESIA INHALATION

Model Number MICROBLENDER

Device Problems Device Operates Differently Than Expected (2913); Improper Device Output (2953)

Patient Problem No Patient Involvement (2645)

Event Date 06/12/2017

Event Type  malfunction  

Manufacturer Narrative

Carefusion file identification: (b)(4).Any additional information received from the customer will be included in a follow-up report.(b)(4).The carefusion field service engineer reported to have evaluated the suspect device and determined the blender is out of tolerance.The suspect device will be sent to carefusion factory service in germany for evaluation and repair.Once a final investigation is completed, a supplemental report will be submitted.

Event Description

The customer reported while using the high flow microblender, the device is out of specifications.The customer reported after setting 90% fraction of inspired oxygen (fio2), the external flow meter reads 84.5%.The customer reported that there is no patient involvement associated with the event.

Manufacturer Narrative

The carefusion factory service in (b)(4) received the suspect microblender for investigation.An investigation was performed and the reported issue was able to be verified.After connecting the blender to a testing station and checking the oxygen (o2) values, the values were found partly out of tolerance.After performing calibration, the issue was resolved.The suspect device was returned to service specifications.

• Brand Name: BIRD HIGH FLOW BLENDER SERIES
• Type of Device: MIXER, BREATHING GASES, ANESTHESIA INHALATION
• Manufacturer (Section D): CAREFUSION, INC; 22745 savi ranch parkway; yorba linda CA 92887
• Manufacturer (Section G): CAREFUSION, INC; 1100 bird center dr.; palm springs CA 92262
• Manufacturer Contact: kristin graf ; 22745 savi ranch parkway; yorba linda, CA 92887
• MDR Report Key: 6713243
• MDR Text Key: 80135667
• Report Number: 2021710-2017-06267
• Device Sequence Number: 1
• Product Code: BZR
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 07/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MICROBLENDER
• Device Catalogue Number: 03800A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2017
• Initial Date FDA Received: 07/14/2017
• Supplement Dates Manufacturer Received: 06/16/2017
• Supplement Dates FDA Received: 07/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2000
• 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