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 Break (1069)

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

Event Date 04/20/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4), emdr submission: unfortunately, no sample was sent for evaluation.A lot number was not provided for evaluation.At this time it¿s not possible to review the device history record for any extraordinary event that could contribute to the defect reported.Based on similar complaints, the filter is ultrasonic welded together.It was noticed during assembly of this filter, that if the operator of the ultrasonic welder does not hold the button until the weld is complete the filter will not be welded completely.To correct and prevent this issue from continuing to occur, a sensor was installed on the welding machine, in order to have an automatic control on the finish of the welding cycle to alleviate the human factor of not pushing the button long enough.(b)(4).

Event Description

Filter has fallen apart during a case.It seems to be happening after the temperature of the filter has been equal to the patient's exhaled breath for a short time.

• 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; 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: 5866271
• MDR Text Key: 52427099
• Report Number: 8030673-2016-00203
• 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
• Report Date: 04/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2016
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2016
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: N
• Patient Sequence Number: 1