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

Model Number AGNX2944

Device Problem Break (1069)

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

Event Date 06/28/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4) initial emdr submission.A shipping label was provided to the customer and at this time we are awaiting for the sample to arrive from the customer.There was no patient harm related to this issue.(b)(4).

Event Description

The 5708hepa filter that is attached to the circuit came apart during a procedure.The defect is with the hmef, not the circuit.There was no patient harm during this incident.The filter broke in two at the weld line.Last break was during patient use.

Manufacturer Narrative

Results of investigation: one filter was received for evaluation and during visual inspection the broken filter was observed.The complaint has been confirmed.The device history record for the lot reported was evaluated for any issues related with this customer report and no issues were found.This filter is welded together by an ultrasonic welding machine.We have reviewed all of our processes regarding this issue and have noted that there is no indication that the process, machine or manufacturing personnel are related to the failure since the procedure provides clear instructions regarding the proper way to operate the ultrasonic welding machine and there are also controls in place to alert the manufacturing personnel when the cycle of the ultrasonic welding is not completed.Based on the investigation, the root cause could not be determined; a corrective and preventative action plan has been initiated to further propose a root cause and applicable action plan of the issue reported.

• Brand Name: ANES CIRCUIT, ADULT, 72 IN CORR, 3L BAG
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION, INC; cerrada vía de la producción; no. 85., parque industrial mex; mexicali baja california norte ; MX
• Manufacturer Contact: jill rittorno ; 22745 savi ranch parkway; yorba linda, CA 92887
• MDR Report Key: 5826214
• MDR Text Key: 51357331
• Report Number: 8030673-2016-00188
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AGNX2944
• Device Lot Number: 0000924080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1