MAUDE Adverse Event Report: VYAIRE MEDICAL, INC ANES CIRCUIT, 90 IN EXP, 1L BAG; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Catalog Number B1734XX4

Device Problem Occlusion Within Device (1423)

Patient Problem Low Oxygen Saturation (2477)

Event Date 06/15/2017

Event Type  Injury  

Manufacturer Narrative

Vyaire has received the complaint device and has finished the required decontamination procedure.The sample has been shipped to the manufacturing plant for further analysis.A follow up mdr will be sent once the investigation has been completed.

Event Description

Customer reported that the "circuit passed pressure test on ge anesthesia machine.Patient started to desat, they put on new circuit and everything was ok.There was a flap in the area of the wye between the 2 hoses.Product was used on patient, no patient harm.".

Manufacturer Narrative

Investigation results: one opened sample was received for evaluation.The sample was inspected and a leak test was performed.The sample failed the leak test in the wye component p/n r5160ya, after performing further evaluation it was detected that the wye was broken.The dhr was reviewed for the lot number reported, and no issues were found that may have contributed to the reported issue.Two years of complaints were reviewed and no adverse trend was detected.Based on the investigation, it is possible that the wye was misaligned while it was being assembled by the press and this created the crack condition in the wye.To correct this issue, the assembly personnel were notified and retrained on the procedure regarding the equipment press.

• Brand Name: ANES CIRCUIT, 90 IN EXP, 1L 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: 6708014
• MDR Text Key: 79889921
• Report Number: 8030673-2017-00352
• 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: B1734XX4
• Device Lot Number: 0001039746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2017
• 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