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

Model Number MICROBLENDER

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

Patient Problem No Patient Involvement (2645)

Event Date 02/18/2015

Event Type  malfunction  

Event Description

The following description of the event was documented by a carefusion technical support specialist in response to an email from the distributor in (b)(6)."oxygen concentration readings failed pre-delivery inspection out of spec.Out of box failure 21:23.6, 30:29.1, 60:56.1, 90:83.2, 100.97.2".

Manufacturer Narrative

(b)(4).Carefusion issued a return goods authorization (rga) number for the return of the alleged faulty device for evaluation.As of the march 17, 2015 the alleged faulty device has not been received.Once the alleged faulty device is received and evaluated, a follow-up medwatch report will be submitted.

Manufacturer Narrative

Corrected serial # to (b)(4).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 90290 and found that it is out of calibration at 30%, 60% and 90% o2.At end point calibration sequence # 1, 21%, spec.Is 20.9 to 22.9% reads 21.8%.At set point calibration sequence # 3, 60%, spec.Is 58.0 to 62.0% reads 54.8%.At set point calibration sequence # 4, 90%, spec.Is 88.0 to 92.0% reads 86.1%.At set point calibration sequence # 5, 100%, spec.Is 98.0 to 100.0% reads 98.7%.At set point calibration sequence # 7, 60%, spec.Is 58.0 to 62.0% reads 54.6%.At set point calibration sequence # 8, 60%, spec.Is 57.0 to 63.0% reads 54.9%.At set point calibration sequence # 9, 60%, spec.Is 57.0 to 63.0% reads 53.5%.Additional issues related to complaint; at set point calibration sequence # 2, 30%, spec.Is 28.0 to 32.0% reads 25.0%.The microblender was recalibrated by adjusting the valve seat and the control knob.Finding/root-cause: the microblender was out of calibration at 60% and 90% but was not out of calibration at 21% and 100% as alleged, but was out of calibration at 30%.

• Brand Name: BIRD
• Type of Device: MIXER, BREATHING GASES, ANESTHESIA INHALATION
• 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: 4623618
• MDR Text Key: 5575796
• Report Number: 2021710-2015-00553
• 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: 02/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2015
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2015
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/18/2015
• Device Age: 1 MO
• Event Location: Other
• Date Manufacturer Received: 04/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1