MAUDE Adverse Event Report: CAREFUSION CAREFUSION

Model Number MICROBLENDER

Device Problems Out-Of-Box Failure (2311); Inaccurate Delivery (2339); Failure to Calibrate (2440)

Patient Problem No Patient Involvement (2645)

Event Date 12/19/2014

Event Type  malfunction  

Event Description

The following description of event was documented by a carefusion tech support specialist in response to an email from the distributor in (b)(6)."obf pn 03920a microblender getting 27 set at 21, getting 94 set at 100.Blender failed pre-delivery inspection.Blender is reading high on 21% o2 values, and low on 100% o2 values.Unable to resolve through calibration.".

Manufacturer Narrative

The foreign distributor did not submit a user facility/importer report to the manufacturer.(b)(4).The alleged faulty device was received by carefusion on (b)(4) 2015, routed to the carefusion failure analysis lab and staged for eval.Once the eval is complete, a f/u medwatch report will be submitted.

Manufacturer Narrative

Failure analysis: microblender pn: 03920a, sn: (b)(4) was received into the carefusion failure analysis lab for investigation.The carefusion failure analysis lab technician examined the microblender and found that it is out of calibration.The microblender was tested on test station # 10464 per drs (b)(4) and found that it is out of calibration at 21%, 30%, 60%, 90% and 100% o2.At end point calibration sequence # 1, 21%, spec.Is 20.9 to 22.9% reads 24.3%.At set point calibration sequence # 2, 30%, spec.Is 28.0 to 32.0% reads 24.4%.At set point calibration sequence # 3, 60%, spec.Is 58.0 to 62.0% reads 55.2%.At set point calibration sequence # 4, 90%, spec.Is 88.0 to 92.0% reads 89.1%.At set point calibration sequence # 5, 100%, spec.Is 98.0 to 100.0% reads 97.0%.At set point calibration sequence # 7, 60%, spec.Is 58.0 to 62.0% reads 55.2%.At set point calibration sequence # 8, 60%, spec.Is 57.0 to 63.0% reads 55.7%.At set point calibration sequence # 9, 60%, spec.Is 57.0 to 63.0% reads 54.9%.The microblender could not be recalibrated by adjusting the control knob and or valve seat.The poppet pn: 03929 was replaced and was then, able to recalibrate the microblender.Finding/root-cause: duplicated, the microblender is out of calibration at 21% and 100%, complaint allegation.Also, found that unit is out of calibration at 30%, 60% and 90%.The microblender has a defective poppet pn: 03929.

• Brand Name: CAREFUSION
• Manufacturer (Section D): CAREFUSION; yorba linda CA
• Manufacturer (Section G): CAREFUSION; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: jill rittorno ; 75 n. fairway drive; vernon hills, IL 60081 ; 8473628056
• MDR Report Key: 4438120
• MDR Text Key: 5394268
• Report Number: 2021710-2015-00085
• Device Sequence Number: 1
• Product Code: BZR
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K883038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor,distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2015
• 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: 03920A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/13/2015
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/19/2014
• Device Age: 2 MO
• Event Location: Other
• Date Manufacturer Received: 07/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1