MAUDE Adverse Event Report: TELEFLEX INCORPORATED HUDSON RCI; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Model Number IPN913728

Device Problems Fluid/Blood Leak (1250); Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/25/2020

Event Type  malfunction  

Event Description

Surgical patient in the icu was on a high flow nasal cannula.Respiratory therapist noticed, while changing the water bottle on the patient's high flow nasal cannula set up, the water concha column malfunctioned, sending water at 50l/min into the patient's nares.In an effort to prevent this from occurring, as this has happened before, patient was removed from high flow system altogether prior to changing the water bottle and placed on 100% o2 non-rebreather mask.The respiratory therapist monitored the water concha for roughly 5 minutes before placing the nasal cannula back on the patient.After leaving the room, less than 5 minutes later, the patient began yelling for help as water was coming through the high flow system and shooting up her nose.Patient's spo2 desaturated to roughly 60%.Rn removed high flow system from patient and placed on non-rebreather mask.After roughly 10 minutes, patient's spo2 returned to normal limits.System was pulled completely from patient's room and replaced with new system with the older style concha.Malfunctioning concha has been saved and given to respiratory administration.

• Brand Name: HUDSON RCI
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 9823526
• MDR Text Key: 183105005
• Report Number: 9823526
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 03/03/2020,02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: IPN913728
• Device Catalogue Number: 2410
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/03/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24455 DA
• Patient Weight: 57