MAUDE Adverse Event Report: CAREFUSION ANES CKT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Model Number A8E520AX

Device Problems Crack (1135); Leak/Splash (1354)

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

Event Date 12/29/2014

Event Type  Injury  

Event Description

Med watch report no: mw5039890 received.Follow up info received 30 mar 2015 email from customer stating "i will look for the retained sample; however, the crack in the hme housing caused a significant (and hard-to-find) circuit leak.We did have other reports in the same period, but no samples retained".

Manufacturer Narrative

(b)(4).Should a device become available a follow up emdr will be submitted.

Manufacturer Narrative

(b)(4).Follow up- a sample was not received for evaluation.However, since a lot number was received a device history record was conducted and no problems were indicated that would have contributed to this issue.The component within this reported issue is a supplied product from another manufacturing company.Without the sample available for evaluation a definite root cause cannot be confirmed.However, the most probable root cause is that the hme filter cracked due to an uneven distribution of plastic material, caused by a molding defect, thus causing a weakness in the area where the break allegedly occurred.The mold which caused this defect has been identified and removed from production by the manufacturing facility.A scar has been sent to the manufacturer of the filter to complete the investigation.

Manufacturer Narrative

This supplemental is being filed due to a retrospective review of mdr submissions.Corrections and additional information has been completed.Additional info: initial emdr submission codes; investigation completion date.(b)(4).

• Brand Name: ANES CKT
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): CAREFUSION; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION; cerrada vía de la producción; no. 85., parque industrial mex; mexicali baja california norte 21600 ; MX 21600
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 4707806
• MDR Text Key: 18627471
• Report Number: 2242551-2015-00024
• 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: User Facility,user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: A8E520AX
• Device Lot Number: 10293827
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention