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

Catalog Number A5U520X0

Device Problem Partial Blockage (1065)

Patient Problem Hypoventilation (1916)

Event Date 11/15/2016

Event Type  Injury  

Manufacturer Narrative

Initial mdr submission: no sample is available, however photos were provided by the end user of the end cap of the iv set inside of the elbow of the circuit.If any additional information becomes available a supplemental submission will be filed.End user states, patient did not experience any long term clinical effects.(b)(4).

Event Description

Customer stated via email ¿i responded to a call for help in an operating room.A patient who had a long, uneventful operation had been extubated and was now hypoventilating and needed re-intubation.After re-intubation, the patient could not be ventilated.The intubation which was easy was done over again, but still the patient could not be ventilated.At some point, someone got an ambu bag and the patient could easily be ventilated via the endotracheal tube.I inspected the anesthesia circuit afterward, and i found an end cap from an iv tubing set in the elbow of the anesthesia circuit.The end cap of carefusion's smartsite infusion set (reference (b)(4)) and their secondary site (reference (b)(4)) fit perfectly into the elbow of their vital signs adult anesthesia breathing circuit a5u520x0 and completely obstructed the circuit.It could not be noticed even when looking directly at it because it is all clear plastic.Don't ask me how this happened, but i know that these caps get left around on the top of the anesthesia machines and at the end of surgery after extubation, the breathing circuits often come apart at the elbow.Somehow, the cap got into the breathing circuit.If the manufacturer of the iv tubing sets made the end caps with some color in it, then you could detect when this happened¿.

Manufacturer Narrative

Follow up submission: no sample was provided for evaluation.However photos were provided and it was observed that the elbow has a connector inside.But according to the bill of material (bom) and also the visual aid for the reported finished good code, the connector observed in the picture is not part of the materials used for the assembly of the circuit.Therefore, the reported failure mode (occluded condition) could not be confirmed as a manufacturing defect.The connector that is inside of the elbow component did not originate at the manufacturing facility.At this time, no corrective action will be implemented since the issue did not originate at the manufacturing facility.

• 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 dr; 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: 6134994
• MDR Text Key: 61144428
• Report Number: 8030673-2016-00265
• 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: consumer,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A5U520X0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2017
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CAREFUSION'S SMART SECONDARY SITE (B)(4); CAREFUSION'S SMARTSITE INFUSION SET (B)(4)
• Patient Outcome(s): Required Intervention