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

Catalog Number AGNX204Z

Device Problem Break (1069)

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

Event Date 07/05/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This complaint sample is unavailable for evaluation.Customer stated there has been no adverse impact to the patient.If any additional information becomes available a supplemental submission will be completed.(b)(4).

Event Description

Filter fell apart while the patient was intubated during the case.There was no direct patient harm.No lot number available.

Manufacturer Narrative

Carefusion is unable to review the device history record as no lot number was provided.Carefusion is unable to determine if manufacturing personnel, manufacturing process or machines are related to this reported issue since the sample is not available for evaluation.However, there are controls in place to prevent this issue from occurring.The component that was reported as breaking apart is ultrasonically welded together.The ultrasonic welding machine has controls and a sensor in place to assure that the welding cycle is completed.If the cycle is not completed the controls alert the operator of the incomplete weld of the component.At this time a root cause could not be determined, for this reason a corrective and preventative action plan has been initiated to further evaluate this issue.(b)(4).

• 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: 5830295
• MDR Text Key: 51734359
• Report Number: 8030673-2016-00194
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AGNX204Z
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2016
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: N
• Patient Sequence Number: 1