MAUDE Adverse Event Report: CAREFUSION CAREFYSUIB; NUXERM BREATGUBG GASESM ABESTGESUA UBGAKATUIB.BZR

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 01/12/2015

Event Type  malfunction  

Event Description

The following description of the event was copied by a carefusion technical support specialist from an email from the distributor in (b)(6)."obf blender failed pre-delivery inspection.Blender is reading high on 21% o2 values (29%), and low on 600% o2 values (54.7%).Unable to resolve through calibration.Values for air and oxygen inlet pressures at 50psi: 21% = 29, 30% = 29.2, 60% = 54.7, 90% = 90.4, 100% = 100".

Manufacturer Narrative

(b)(4).The alleged faulty device was received by carefusion on 02/03/2015, routed to the carefusion failure analysis lab and staged for evaluation.Once the evaluation is complete a follow-up medwatch report will be submitted.

Manufacturer Narrative

Failure analysis: microblender pn: (b)(4), 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 # (b)(4) per (b)(4) and found that it is out of calibration at 21%, 30%, and 60% o2.At end point calibration sequence # 1, 21%, spec.Is 20.9 to 22.9% reads 25.8%.At set point calibration sequence # 2, 30%, spec.Is 28.0 to 32.0% reads 25.8%.At set point calibration sequence # 3, 60%, spec.Is 58.0 to 62.0% reads 53.4%.At set point calibration sequence # 7, 60%, spec.Is 58.0 to 62.0% reads 53.4%.At set point calibration sequence # 8, 60%, spec.Is 57.0 to 63.0% reads 53.5%.At set point calibration sequence # 9, 60%, spec.Is 57.0 to 63.0% reads 53.2%.Additional issues related to complaint; failed, at ¿flow rate¿ sequence # 12, spec.Is >/=30.0 lpm min, reads 23.Failed, at ¿flow rate¿ sequence # 15, spec.Is >/=30.0 lpm min, reads 23.The microblender was recalibrated by adjusting the valve seat and the control knob.Finding/root-cause: duplicate, the microblender is out of calibration, complaint allegation.

• Brand Name: CAREFYSUIB
• Type of Device: NUXERM BREATGUBG GASESM ABESTGESUA UBGAKATUIB.BZR
• 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: 4544423
• MDR Text Key: 20784740
• Report Number: 2021710-2015-00265
• Device Sequence Number: 1
• Product Code: BZR
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 01/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MICROBLENDER
• Device Catalogue Number: 03920A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/03/2015
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/14/2015
• Device Age: 2 MO
• Event Location: Other
• Date Manufacturer Received: 03/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2014
• 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