MAUDE Adverse Event Report: CAREFUSION, INC ANES CIRCUIT, ADULT, 108 IN EXP, 3L BAG; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Catalog Number A5U52XX4

Device Problem Crack (1135)

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

Event Date 07/28/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4) -exp-initial emdr submission.The customer stated a sample is available.Customer advocacy has provided the customer with a shipping label for the samples return.At this time we are awaiting for the sample to arrive at our facility.If any additional information becomes available a follow-up submission will be filed.(b)(4).

Event Description

"just after intubation i was unable to bag ventilate my patient and i could hear a leak in the breathing system.I examined the ventilator, the soda lime scrubber system, the connections for the anesthesia circuit, and the anesthesia circuit itself.I could localize the sound of the leak to the top of the soda lime scrubber system and the attachments for the breathing circuit.Fortunately i was able to visualize a large crack in the vital signs breathing circuit.The crack was on the connector for the circuit and this piece contains a filter.As i was unable to ventilate the patient with this large leak in my breathing circuit, i had to quickly replace the breathing circuit with a new circuit that was intact.This immediately fixed the problem".

Manufacturer Narrative

One circuit sample was received and evaluated.Per visual inspection on the two filters for the circuit, it was observed that one filter had a crack.Therefore the issue reported was confirmed.The filters were sent for infrared spectroscopy testing and the results concluded that there is no difference between the samples and the applicable reference material submitted.Two years of complaints was reviewed and no trend was observed.The filter is visually and functionally inspected prior to the final assembling and packaging phase.There is no indication that the cracked condition occurred during the manufacturing process.The quality engineers tried to duplicate the failure observed in the samples and the failure could not be duplicated during the manufacturing process.Based on the investigation, we are unable to determine a root cause since there is no evidence that the cracked condition on the filter occurred during the manufacturing process.It is possible that this condition may have happened outside the manufacturing process during shipping or handling process.At this time no corrective action will be implemented.

• 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: 5850214
• MDR Text Key: 52423805
• Report Number: 8030673-2016-00198
• 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: 11/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A5U52XX4
• Device Lot Number: 0000935978
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/28/2016
• Initial Date FDA Received: 08/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1