MAUDE Adverse Event Report: CAREFUSION/BD ANES CIRCUIT, ADULT, 72 IN CORR, 3L BAG; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Catalog Number AGNX204Z

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/23/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).It has been confirmed the complaint sample is not available for evaluation.Attempts have been made by carefusion/bd to gain additional information from the customer and end user regarding situation reported with device.Carefusion/bd is still waiting for additional information regarding reported issue.If a sample or any additional information becomes available a follow up emdr will be submitted.(b)(4).

Event Description

The customer reported that a circuit hme broke in half during a thoracic case.The circuit was being used on a patient when it failed.No patient harm was reported.The affected sample is unviable the end-user believes it was disposed of.

Manufacturer Narrative

Unfortunately, no sample was available for investigation; because of this we could not confirm the failure mode.Carefusion/bd reviewed the device history record for the reported lot number and no issues were found.Carefusion/bd reviewed the manufacturing procedure for correctness and to evaluate for any process improvements.The ultrasonic welding machines (usw) push buttons should be pressed to active usw.The manufacturing procedure specifies that the manufacturing personnel should keep the usw push buttons pressed until the welding cycle is completed.Carefusion/bd saw a need to improve this process.A sensor has been added to eliminate the possibility of human error.This sensor activates an automatic control; to finish the welding process.This stops the operator error of removing the hands before the cycle is completed.Carefusion/bd has enhanced the controls to alert personnel when the welding cycle has not completed.If a welding cycle is not completed the product should be segregated by the manufacturing staff.We have opened a corrective and preventative action plan to continue to investigate and improve on this process.Carefusion/bd will also continue to take and trend for this reported failure mode.

• Brand Name: ANES CIRCUIT, ADULT, 72 IN CORR, 3L BAG
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): CAREFUSION/BD; cerrada vía de la producción; no. 85 parque industrial; mexicali baja california norte ; MX
• Manufacturer (Section G): CAREFUSION/BD; 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
• MDR Report Key: 5814713
• MDR Text Key: 50218048
• Report Number: 8030673-2016-00185
• 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: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/24/2016

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 Catalogue Number: AGNX204Z
• Device Lot Number: 0000942703
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/23/2016
• Initial Date FDA Received: 07/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/24/2016
• 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: N
• Patient Sequence Number: 1