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 Circuit Failure (1089)

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

Event Date 06/17/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial emdr submission carefusion has reached out to customer to provide the complaint device for further investigation.The customer indicated that the sample was shipped back to carefusion.A follow up mdr will be sent once the investigation has been completed.(b)(4).

Event Description

The end-user reported a circuit failure at the end of a surgery case.End-user reported no harm.The filter on the circuit separated.

Manufacturer Narrative

Results of investigation: the device history record for the reported lot number was evaluated for any issues related with the report failure (filter housing separating), and no issues were found.One sample was received for evaluation.Upon evaluation of the received sample we did observe the fall apart condition; therefore the reported failure was confirmed.A full evaluation of manufacturing methods was performed.There is no indication that the manufacturing personnel are contributing to the reported failure mode as control measures in the manufacturing process is in place to prevent this issue.The procedure provides the instructions needed to perform a complete ultra-sonic weld (usw) cycle.The usw push buttons should be pressed to start and complete the weld cycle.The usw machine has had a sensor put in placed to have an automatic control of the finish cycle to avoid operator error by removing the hands before the cycle has completed.If a weld cycle is not completed we have implemented further controls to alert the personnel that the cycle did not properly complete.At this time, the root cause of the reported issue could not be determined.This issue will be internally investigated within carefusion.

• 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: 5791824
• MDR Text Key: 50218959
• Report Number: 8030673-2016-00181
• 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: 06/17/2016

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: 000939596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2016
• Initial Date FDA Received: 07/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1