MAUDE Adverse Event Report: VYAIRE MEDICAL, INC ANES CIRCUIT, ADULT, 75 IN EXP, 3L BAG; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Catalog Number A4FX2004

Device Problem Disconnection (1171)

Patient Problem Low Oxygen Saturation (2477)

Event Date 05/31/2017

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.(b)(4).

Event Description

The customer reported that the circuit itself has been disconnected from the machine.The crna has confidently intubated the patient and we note lack of co2 because the circuit became disconnected.This has resulted in decreased oxygen levels for these patients.

Manufacturer Narrative

Investigation results: no physical sample was received for evaluation.However, the dhr for the lot number reported was reviewed and no issues were found related to the disconnection reported.The complete lot was manufactured and released per our internal procedure.In addition, the dhr of the p/n 65-20011 and no issues were identified that could have been involved with the disconnect condition.Since no sample was provided for evaluation, a root cause could not be determined.No corrective actions are indicated at this time.We will continue to track and trend this issue.

• Brand Name: ANES CIRCUIT, ADULT, 75 IN EXP, 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: 6681661
• MDR Text Key: 78844983
• Report Number: 8030673-2017-00350
• 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: 10/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A4FX2004
• Device Lot Number: 0001066957
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/31/2017
• Initial Date FDA Received: 06/30/2017
• Supplement Dates Manufacturer Received: 08/25/2017
• Supplement Dates FDA Received: 10/12/2017
• Was Device Evaluated by Manufacturer?: No
• 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