MAUDE Adverse Event Report: BIOMEDICAL DEVICES, INC. TRI-ANIM AIR OXYGEN BLENDER; BMD AIR/OXYGEN BLENDER

Model Number FOTA1000

Device Problem Material Frayed (1262)

Patient Problems Low Oxygen Saturation (2477); Respiratory Arrest (4461)

Event Date 02/11/2021

Event Type  Injury  

Manufacturer Narrative

The reported issue states, " the blender was in use on an infant".While the staff was turning the knob, the levels of oxygen were not increasing.The patient was not receiving the required levels of oxygen and coded.The customer believes the patient was intubated, and was manually provided with oxygen until the blender was swapped out with one that was functioning properly.The unit did not test to oem standards.In reference to service manual titled "carefusion bird high flow blender rev 2013", specifically section "d.Calibration procedure", an oxygen concentration evaluation was performed, and the blender was only giving 33.5% on the auxiliary outlet and 21.8% on the primary outlet.The blender would not increase or decrease oxygen mixture when turning the knob.The blender did not show any signs of physical damage or mishandling from the facility.Once the unit was taken apart, it was discovered that the diaphragms inside the diaphragm blocks had been torn and deteriorated.The diaphragms were causing the blender to not regulate the oxygen concentration.The diaphragms were installed on 1/17/20 and had been working for one year before the unit failed.Upon further inspection of the unit, there were no traces of any damages to the o-rings, springs, or filters.All of the rubber o-rings held their physical composition and were sealing the blender properly.Upon review of all objective evidence, the customer complaint was confirmed.The root cause was determined to be related to harsh conditions that resulted in a reduced life expectancy of the blenders diaphragms.After reviewing the maintenance records, ahs biomedical engineering staff noticed that most nicu rooms have "incorrect labeling" and "leakage" on oxygen and medical air gas.The maintenance records do not specify any details on those findings.Finally, we noticed that the calibrate date on analysis equipment were last calibrated in 2019.No additional patient or event information is available.This type of event will continue to be monitored.

Event Description

The reported issue states, " the blender was in use on an infant.While the staff was turning the knob, the levels of oxygen were not increasing.The patient was not receiving the required levels of oxygen and coded.The customer believes the patient was intubated, and was manually provided with oxygen until the blender was swapped out with one that was functioning properly.

• Brand Name: TRI-ANIM AIR OXYGEN BLENDER
• Type of Device: BMD AIR/OXYGEN BLENDER
• Manufacturer (Section D): BIOMEDICAL DEVICES, INC.; 8 bishop ln.; madison CT 06443
• Manufacturer (Section G): AVANTE HEALTH SOLUTIONS; 212 avenida fabricante; san clemente CA 92672
• Manufacturer Contact: jenna vargas ; 212 avenida fabricante; san clemente, CA 92672 ; 8004495328
• MDR Report Key: 11386956
• MDR Text Key: 233821933
• Report Number: 3007409280-2021-00002
• Device Sequence Number: 1
• Product Code: BZR
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K925982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FOTA1000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 4 DA