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

Catalog Number AFNX2004

Device Problem Occlusion Within Device (1423)

Patient Problem Low Oxygen Saturation (2477)

Event Date 07/19/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4) has received the complaint device and is currently waiting for the sample to be released to the manufacturing facility by mexico's customs.Vyaire will be performing an investigation into the reported issue.A follow up mdr will be sent once the investigation has been completed.(b)(4).

Event Description

The customer reported "we have a circuit that came from the manufactory completely sealed closed.Dr.(b)(6) was in the case and discovered the occluded circuit, after taking it apart.This is a huge patient safety concern.Product was used on patient.Patient was given more bronchodilators than needed and used ambubag to assist with breathing.The peak inspiratory pressure alarm sounded due to the partial occlusion alerting the end-user".

Manufacturer Narrative

The affected opened sample was received for further evaluation.A visual inspection was performed to the unit, and a translucent plastic layer was observed as reported by the customer; therefore the reported failure has been confirmed.This plastic layer occluded one of the ports on the dual lumen machine end of the circuit.Vyaire was able to confirm that this particular connector was manufactured in cavity 14.A two year look back of complaint trends has been completed and no trend was observed.After a thorough investigation of the manufacturing procedure it was identified that an interlock core pin was broken on the equipment for cavity 14.The broken core pin caused the pin to stay lodged within the core.This then caused a small gap between the core pin and the core big enough to allow a thin layer of translucent plastic for form.The quality engineers have been able to replicate this failure.It was found that after this circuit was produced with the occlusion, the broken core pin lodged itself completely within the core and the gap was eliminated.This is why during the same production no other units were affected.Vyaire has notified the quality personnel from the assembly and molding areas to be aware of this type of failure.Nine different lots from the available inventory at the manufacturing facility have been audited to confirm that no other circuits have this occluded failure mode.No more occluded connectors have been found.Production on the mold that produced the affected circuit has been stopped as of (b)(6) 2017 and will resume after all five interlock core pins have been repaired.

• Brand Name: ANES CIRCUIT, ADULT, 72 IN CORR, 3L BAG
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): VYAIRE MEDICAL, INC; cerrada vía de la producción; no. 85 parque industrial; mexicali baja california norte ; MX
• Manufacturer (Section G): VYAIRE MEDICAL, INC; cerrada vía de la producción; parque industrial mex; mexicali baja california norte ; MX
• Manufacturer Contact: mindy faber ; 26125 n. riverwoods blvd.; mettawa, IL 60045
• MDR Report Key: 6793797
• MDR Text Key: 82672065
• Report Number: 8030673-2017-00360
• 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: 10/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AFNX2004
• Device Lot Number: 0001088042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention