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 australia."oxygen concentration readings failed pre-delivery inspection out of spec.Out of box failure 21:30.3, 30:32.5, 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

(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 (b)(4) and found that it is out of calibration at 21% and 30% o2.At end point calibration sequence # 1, 21%, spec.Is 20.9 to 22.9% reads 26.7%.At set point calibration sequence # 2, 30%, spec.Is 28.0 to 32.0% reads 27.8%.At set point calibration sequence # 3, 60%, spec.Is 58.0 to 62.0% reads 58.0%.At set point calibration sequence # 4, 90%, spec.Is 88.0 to 92.0% reads 91.1%.At set point calibration sequence # 5, 100%, spec.Is 98.0 to 100.0% reads 99.6%.At set point calibration sequence # 7, 60%, spec.Is 58.0 to 62.0% reads 58.8%.At set point calibration sequence # 8, 60%, spec.Is 57.0 to 63.0% reads 59.2%.At set point calibration sequence # 9, 60%, spec.Is 57.0 to 63.0% reads 58.7%.The microblender was recalibrated by adjusting the valve seat and the control knob.However, it was found that the best calibration yielded readings of at 21%; 22.7, 30%; 29.2, 60%; 60.3, 90%; 89.1, 100%; 100.0.The poppet pn: 03929 was replaced with a known good poppet and now the microblender can be calibrated as follows 21%; 21.3, 30%; 29.9, 60%; 59.5, 90%; 89.5, 100%; 99.6.Duplicated, the microblender is out of calibration at 21% and 30% but did not duplicate microblender out of calibration at 60%, 90% and 100% complaint allegation.Finding/root-cause: the microblender was out of calibration due to a faulty poppet pn: 03929.

• 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: 4623636
• MDR Text Key: 18035993
• Report Number: 2021710-2015-00552
• 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

• 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
• Initial Date Manufacturer Received: 02/18/2015
• Initial Date FDA Received: 03/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2015
• 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