MAUDE Adverse Event Report: CAREFUSION, INC ANES CIRCUIT, ADULT, 108 IN EXP, 3L BAG; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Catalog Number A4UX2044

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/25/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial emdr submission- the complaint device was received by carefusion/bd and has been forwarded to the manufacturing site for further evaluation.A follow up will be submitted once the investigation is complete, or if any additional information is provided.(b)(4).

Event Description

Staff was using the anesthesia circuit, and observed an error leak.It was also noticed that the hepa filter fell apart.The sales representative was present at the time of the failure.A leak was noticed during the o.R.Case when the vent alarmed.The end-user quickly found the filter had broken into two pieces.There was no harm to the patient.

Manufacturer Narrative

Results of investigation: the device history record for the reported product could not be reviewed; the lot number was not provided by the end-user.One filter was received for evaluation, and during inspection, carefusion/bd observed the "fell apart" condition; therefore the failure mode reported was confirmed.Based on the investigation results and similar reports, the root cause is identified as equipment failure.The following internal corrective actions have been implemented: -a sensor was installed in the welding machine to ensure that the welding procedure will automatically finish its welding cycle.This will avoid the operator error of removing the hands before the cycle is completed.-carefusion/bd has added a test to the manufacturing procedure to detect any un-welded units.-carefusion/bd engineers have also completed a study to determine the amount of time needed for the product to cool before conducting a dimensional inspection.-manufacturing personnel have also been notified of this failure.

• Brand Name: ANES CIRCUIT, ADULT, 108 IN EXP, 3L BAG
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): CAREFUSION, INC; cerrada vía de la producción; no. 85 parque industrial; mexicali baja california norte ; MX
• Manufacturer (Section G): CAREFUSION, INC; cerrada vía de la producción; no.85 parque industrial; mexicali baja california norte ; MX
• Manufacturer Contact: jill rittorno ; 22745 savi ranch parkway; yorba linda, CA 92887 ; 7149227830
• MDR Report Key: 5752228
• MDR Text Key: 49033831
• Report Number: 8030673-2016-00178
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A4UX2044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1