MAUDE Adverse Event Report: VYAIRE MEDICAL BLENDER; MIXER, BREATHING GASES, ANESTHESIA INHALATION

Model Number	BLENDER
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	02/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Vyaire medical received uf report: (b)(4).Vyaire medical, inc.Reached out to the customer to obtain additional information.The serial number was provided and confirmed.Based on the information provided in the uf report: (b)(4), the biomed reported the device was repaired and returned back to service.
Event or Problem Description
The customer reported while undergoing extracorporeal membrane oxygenation (ecmo) post oxygenator therapy, the patient's partial-arterial oxygen (pa02) level is reading seventy (70) mmhg.The customer performed troubleshooting.The oxygen tubing and filter was changed.The customer reported no improvements to the patient were reported with the post oxygenator pa02 greater than 500 mmhg.The customer determined the most likely cause of the issue was due to the blender dial knob.The customer reported it found to be loose.The customer reported verified the device with an analyzer check and reported reading only twenty-one percent (21%) oxygen.

• Brand Name: BLENDER
• Common Device Name: MIXER, BREATHING GASES, ANESTHESIA INHALATION
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 8599906
• Report Number: 2021710-2019-10245
• Device Sequence Number: 11265396
• Product Code: BZR
• UDI-Device Identifier: 10846446002126
• UDI-Public: (01)10846446002126
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/15/2019

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
• Operator of Device: Health Professional
• Device Model Number: BLENDER
• Device Catalogue Number: 10047A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 05/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 6 DA
• Patient Weight: 109