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 No Known Impact Or Consequence To Patient (2692)

Event Date 05/31/2017

Event Type  Injury  

Manufacturer Narrative

It has been confirmed by vyaire that the complaint sample is not available for evaluation.Attempts have been made by customer advocacy to gain additional information from the customer and end user regarding the situation reported with the device.If a sample or any additional information becomes available a follow up emdr will be submitted.(b)(4).

Event Description

The customer reported i have had these bags slip off the machine arm way too easily.I have had it happen multiple times on the same patient at the worst possible moments (during induction and emergency).It causes the practitioner to take their hands off the patient and scramble to reconnect the bag to the machine.

Manufacturer Narrative

Investigation results: no physical sample was provided for evaluation.The dhr however, was reviewed for the lot number reported and no issues were found that may have contributed to the disconnection reported.The complete lot was manufactured and released per our internal procedures.In addition, part number r5063ebma sub assembly for the finished good code of a4fx2004 was reviewed and no issues were identified that may have contributed to this reported issue.Since the sample was not provided, the root cause is unable to be determined.No corrective actions are indicated at this time.We will continue to track and trend this reported failure.

• 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: 6678998
• MDR Text Key: 78764363
• Report Number: 8030673-2017-00349
• 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

• Date FDA Received: 06/29/2017
• 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
• Date Manufacturer Received: 08/25/2017
• 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