MAUDE Adverse Event Report: CAREFUSION, INC MICROBLENDER; MIXER, BREATHING GASES, ANESTHESIA INHALATION

Model Number MICROBLENDER

Device Problem Improper Device Output (2953)

Patient Problem No Patient Involvement (2645)

Event Date 03/09/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).In the event the additional information is received, a follow-up report will be submitted.Results of investigation: the carefusion factory service technician was able to duplicate the reported issue and confirmed that the oxygen was being delivered at 81 percent when it was set to 90 percent.The root cause was due to the blender being out of specification.There unit received overhaul service, was tested, and it meets all service specifications.(b)(4).

Event Description

The customer stated that the microblender fails the oxygen test.The customer requested that the blender be sent in for repair.There was no patient involvement at the time reported incident.

• Brand Name: 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: 5553179
• MDR Text Key: 42076774
• Report Number: 2021710-2016-03472
• Device Sequence Number: 1
• Product Code: BZR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2016
• 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: 03800F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2002
• 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