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

Model Number MICROBLENDER

Device Problems Device Operates Differently Than Expected (2913); No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/24/2016

Event Type  Injury  

Manufacturer Narrative

Should any additional information be received by the customer then an additional report will be submitted.(b)(4).At this time carefusion is waiting for components from customer for evaluation.

Event Description

The customer reported that this microblender was being used for the first time and it had no flow output.The unit reportedly was not blowing any air out of the air port.The customer stated that this occurred during an infant resuscitation.An alternate gas source was provided with a known good blender.The customer stated that there was no patient injury associated with this reported event.

• Brand Name: P/N 9320 LOW FLOW AIR/OXYGEN MICROBLENDER
• 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: jill rittorno ; 22745 savi ranch parkway; yorba linda, CA 92887 ; 7149227830
• MDR Report Key: 5593388
• MDR Text Key: 43150507
• Report Number: 2021710-2016-03604
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2016
• 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: 11392
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2015
• 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