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

Model Number MICROBLENDER

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/15/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).At this time, no analysis has been performed on the suspect device.The suspect device will be sent to carefusion's (b)(4) facility for evaluation.After evaluation is complete, the distributor will report findings to the end-user for repair approval.

Event Description

The customer reported while using the p/n 9320 low flow air/oxygen microblender; the unit is not alarming for the pressure difference.The customer reported when the oxygen (o2) source was taken off air was leaking out from the o2 input connection.The customer reported the unit attached to the optiflow device which is feeded by the blender.The issue was noticed during patient use; the customer reported there was no medical intervention required and the device has been taken out of service at this time.The customer reported there is no patient consequence associated with the event.

Manufacturer Narrative

Results of investigation: the carefusion factory service in (b)(4) received the suspect microblender for investigation.An investigation was performed and fault was able to verified.The blender was tested and the alarm range was checked.Upon disassembly the suspect device, the fault was found.The poppet was stuck and the alarm springs were installed incorrectly.The diaphragm had a hold and the check valve was seated wrong.After replacing the poppet, check valve, and diaphragm, the alarm springs were installed and the issue was resolved.The blender was tested for function and calibration.After identifying the root cause, the device history was reviewed and confirmed that the end user had performed the most recent overhaul of the device themselves, in which they disassembled and reassembled the device.It is suspected that the assembly error was a result of the end user improperly assembling the device without properly following the service manual.

• 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: kristin graf ; 22745 savi ranch parkway; yorba linda, CA 92887
• MDR Report Key: 6492579
• MDR Text Key: 72988092
• Report Number: 2021710-2017-05755
• Device Sequence Number: 1
• Product Code: BZR
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K883038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2017
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2007
• 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