MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP NEPTUNE HEATED HUMIDIFIER,CONCHASMART

Catalog Number HUD42500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 05/29/2022

Event Type  Injury  

Manufacturer Narrative

It was reported by the facility that a newborn was placed on heated high flo oxygen via nc at 2 lpm 30% temp 31.9 c.The respiratory therapist was called to the nursery by the nurse, who stated water was in the tubing of the high flow nasal cannula.It was noted that the nasal cannula was not in the baby's nose; it was hanging over the side of the safety rail at the head of the bed.The nurse had taken off the nasal cannula when the respiratory tech was called in because of water in the tubing.When the respiratory tech began to disconnect the equipment from the end of the tubing, closest to the device, water was released from the device, which was very hot.The tubing was disconnected at the heating element.That is when water was coming out of the tubing onto the baby.The doctor examined the baby, which appeared to have redness on the stomach and chin areas.The doctor ordered to change o2 to a non-heated nasal cannula.After the situation was resolved, all of the equipment associated with the water overheating was sequestered.The sample was not returned to the manufacturer for evaluation it was returned to a biomed company utilized by the hospital.There was no impact to the patient's stability or oxygen level as a result of the incident however the newborn did experience second degree burns on the right hand, chest, right and left shoulder, chin and neck areas from water in the circuit.Wound care nurses began following and treating the newborn on 5/29/2022.On 6/6/2022 the wound care nurse reported that all areas of open skin were healed.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

It was reported that a newborn sustained second degree burns after being exposed to hot water from the device that was in the tubing hanging on the side of the bed.

• Brand Name: NEPTUNE HEATED HUMIDIFIER,CONCHASMART
• Type of Device: NEPTUNE HEATED HUMIDIFIER,CONCHASMART
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093
• MDR Report Key: 14753518
• MDR Text Key: 294397268
• Report Number: 1417592-2022-00083
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HUD42500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 1 DA
• Patient Sex: Male
• Patient Weight: 3 KG