MAUDE Adverse Event Report: CAREFUSION, INC ANES CIRCUIT, ADULT, 108 IN EXP, 2L BAG; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Catalog Number GNSFXXGX

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/04/2016

Event Type  Injury  

Manufacturer Narrative

Initial emdr submission- at this time, the customer has not responded to requests for additional information regarding this event.If additional information becomes available, it will be submitted in a follow up report.At this time, carefusion has not received the suspect device/component for evaluation.(b)(4).

Event Description

It was reported by the customer that the green ventilator bag came flying off the machine during manual ventilation; it was after induction and after paralysis was initiated.There was no harm to the patient as quick action ensued.

Manufacturer Narrative

Follow up submission: samples were received for evaluation.The breathing bags were visually inspected.It was found that one of the breathing bags, part number (b)(4), the bushing was disconnected from the liter bag.The other breathing bag with the same part number was found with an incorrect assembly of the tape.In addition the bushing connector was dimensionally inspected and no issues were found.The incorrect assembly of the tape between the liter bag and the bushing could have contributed to the disconnected condition reported.Two years of complaints were reviewed and no trend was observed related to this issue.Based on the investigation, it was found that assembly personnel are related with the failure by not performing a proper assembly between the connections of the bushing and the liter bag with the tape.The white tape is part of the design to prevent a disconnection between these connections.To correct this issue, manufacturing personnel were retrained on the proper assembly of the connections with the white tape.In addition, the assembly instructions will be updated to included visual aides to help the manufacturing personnel when assembling this product.

• Brand Name: ANES CIRCUIT, ADULT, 108 IN EXP, 2L 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: 6038298
• MDR Text Key: 57779094
• Report Number: 8030673-2016-00251
• 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,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: GNSFXXGX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention