FDA Adverse Event Injury Summary report: N

VAPOTHERM PRECISION FLOW SYSTEM

MDR report key: 19428424 · Received May 29, 2024

Report

Report Number
MW5155572
Event Type
Injury
Date Received
May 29, 2024
Date of Event
April 26, 2024
Report Date
May 23, 2024
Manufacturer
VAPOTHERM INC.
Product Code
QAV
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
NURSE
Health Professional
Yes

Narratives

Description of Event or Problem · 0

(B)(6), WHO HAD AN ENDOTRACHEAL TUBE (ETT) WITH IN-LINE SUCTION, WAS BEING TRIALED FOR EXTUBATING THROUGH A T-PIECE BLOW-BY PROCEDURE USING VAPOTHERM PRECISION FLOW AS IS THE CURRENT STANDARD PRACTICE IN THE HOSPITAL. AT THE BEGINNING OF THE PROCEDURE, THE VAPOTHERM ADAPTOR WAS CONNECTED TO THE IN-LINE SUCTION, THEN TO A GENERIC ELBOW, AND THEN TO THE ETT. THIS RESULTED IN THE PATIENT RECEIVING HIGH FLOW OXYGEN WITHOUT AN EGRESS AND CAUSED SUBCUTANEOUS EMPHYSEMA. WE TOOK A CLOSER LOOK AT THE GAPS IN OUR PROCESSES, INCLUDING, LITERATURE ABOUT THE PROPER USE OF VAPOTHERM WITH INTUBATED PATIENTS. WE WERE UNABLE TO OBTAIN ANY EDUCATION OR INSTRUCTIONS THAT ARE AVAILABLE TO THE PUBLIC THAT SUPPORTS ITS USE WITH ETTS OR WITH TUBES WITH IN-LINE SUCTION. WE CONNECTED WITH A VAPOTHERM REPRESENTATIVE WHO STATED THAT VAPOTHERM DEVICES SHOULD NEVER BE USED WITH IN-LINE SUCTION (INTUBATED OR TRACH). THEY ALSO WERE UNABLE TO PROVIDE EXPLICIT WRITTEN CONTRAINDICATIONS WITH THE USE OF THEIR PRODUCT. AN EDUCATIONAL MATERIAL AVAILABLE FOR CONSUMERS TO REVIEW WOULD BE BENEFICIAL IN DETERMINING APPROPRIATENESS OF THE USE OF THE DEVICE AND IN DESIGNING WORKFLOWS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
328746 VAPOTHERM PRECISION FLOW SYSTEM HIGH FLOW/HIGH VELOCITY HUMIDIFIED OXYGEN DELIVERY DEVICE QAV VAPOTHERM INC.

Patients

Seq Age Sex Outcome Treatment
1 60 YR Male Disability| H| L