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

Catalog Number AMN520X4F

Device Problem Partial Blockage (1065)

Patient Problems Hypoventilation (1916); No Consequences Or Impact To Patient (2199)

Event Date 06/14/2017

Event Type  Injury  

Manufacturer Narrative

Vyaire has reached out to customer three times to provide the complaint device for further investigation.A ups label was also provided to the customer each time.Unfortunately, vyaire has not received the complaint device for evaluation or the requested additional information.If a sample or any additional information becomes available a follow up emdr will be submitted.

Event Description

The customer "we recently had a case at one of our campuses in which the anesthesia provider was having extreme difficulty ventilating a patient.It was discovered that the breathing circuit itself was defective and was partially blocked on the shorter expiratory limb side of the circuit that attaches to the anesthesia machine.No injury identified at this date and time".

Manufacturer Narrative

Investigation results: a opened samples was received for evaluation.After a visual inspection, a thin and translucent plastic layer was observed that is occluding one of the.380" ports from 65-20009 machine end.This connector is a component which is used as part of the finished good code of amn520x4f.We were able to observe that the this specific component was molded out of cavity #14.The failure mode was confirmed.The dhr was reviewed for the lot number reported of 0001088107, and no issues were found that could relate to this customer report.Two years of complaints were reviewed from 01jul2015 to 30jun2017 and no trend was identified related to an occlusion or functional issues of this product.The probable root cause is related to equipment failure.As failure mode on 65-20009 dual lumen connector, it was identified that the interlock core pin was broken and stuck tight inside of interlock female core from molding tooling.This failure caused the occluded condition on this component.Once the interlock core pin was broken and stuck in the interlock female core, as the machine continues with its process, the interlock went completely inside the female core.This way the gap was eliminated during the same production and no other lots were affected.Immediate corrective actions consisted of notifying quality personnel from assembly and molding.9 different lot numbers were audited by quality personnel and no further occluded connectors were found.The production was stopped and the 5 interlock core pins from the mold tooling was repaired.Capa (b)(4) was opened to follow up on corrective and preventive actions.

• 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; no.85 parque industrial; mexicali baja california norte ; MX
• Manufacturer Contact: mindy faber ; 26125 n. riverwoods blvd; mettawa, IL 60045
• MDR Report Key: 6708444
• MDR Text Key: 79888202
• Report Number: 8030673-2017-00353
• 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: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AMN520X4F
• Device Lot Number: 0001088107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2017
• 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