MAUDE Adverse Event Report: CAREFUSION BIRD SENTRY BLENDER/ ANALYZER / BIRD SENTRY LOW FLOW BLENDER/ANALYZER; MIXER, BREATHING GASES, ANESTHESIA INHALATION

Model Number MICROBLENDER

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 10/14/2015

Event Type  malfunction  

Manufacturer Narrative

Carefusion file identification number is (b)(4).Any additional information that is provided by the customer will be included in a follow-up report.(b)(4).At this time, carefusion has not received the suspect device component for evaluation.

Event Description

The customer reported while overhauling the micro blender, the flow stopped during testing.The customer did not provide patient information.It is understood that this occurred while in service so at this time there is no patient involvement.

Manufacturer Narrative

Results of investigation: the carefusion failure lab has received the suspect component and determined the alleged faulty blocks are the root cause.The defective balance blocks have been identified as a manufacturing deficiency.The issue has been corrected by replacing the blocks.Carefusion continues to track and trend any incident related to this issue.

Event Description

The customer reported the (b)(6) series blender balance blocks have no recess in the diaphragm area.

• Brand Name: BIRD SENTRY BLENDER/ ANALYZER / BIRD SENTRY LOW FLOW BLENDER/ANALYZER
• 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 ; 75 n. fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 5221730
• MDR Text Key: 31361551
• Report Number: 2021710-2015-02196
• Device Sequence Number: 1
• Product Code: BZR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K973646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/14/2015

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2015
• Initial Date FDA Received: 11/13/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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