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

Model Number LOW FLOW AIR OXYGEN BLENDER

Device Problems No Device Output (1435); Medical Gas Supply Problem (2985)

Patient Problem Death (1802)

Event Date 09/30/2019

Event Type  Death  

Manufacturer Narrative

On november 29, 2019, vyaire medical made several attempts to reach out to the customer for additional information.The customer reported the incident was escalated to cambridgeshire and peterborough clinical commissioning group (ccg) where it is currently under internal investigation.The customer reported it is believed to be an isolated incident.To date, the device is not available for evaluation despite several attempts to contact the customer.No customer response was received.The customer reported as a result of any action taken, the dial on the blender was fixed.Due to the serial number being unknown, no service or maintenance record(s) can be obtained and if the use of external analyzers was used to verify performance.Per instructions of use, the blender should only be service or calibrated by a vyaire trained technician.

Event Description

The customer reported the dial on the low flow air oxygen blender was broken leading to a lower than optimal perfusion.The issue occurred during extracorporeal membrane oxygenation (ecmo) therapy.The customer reported the patient suffered a period of hypoxia.The patient later died of a catastrophic brain injury with root cause undetermined at this time.The customer reported hypoxia is one possible cause to the event.

• Brand Name: BIRD BLENDER
• Type of Device: MIXER, BREATHING GASES, ANESTHESIA INHALATION
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: stanley tan ; 22745 savi ranch pkwy; yorba linda, CA 92887 ; 7149193324
• MDR Report Key: 9511750
• MDR Text Key: 172457697
• Report Number: 2021710-2019-11098
• Device Sequence Number: 1
• Product Code: BZR
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K883038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LOW FLOW AIR OXYGEN BLENDER
• Device Catalogue Number: 03920A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/28/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death