MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON AQUAPAK 301 SW 340 ML; RESPIRATORY GAS HUMIDIFIER

Catalog Number 003-01

Device Problem Burst Container or Vessel (1074)

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

Event Date 11/27/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Medwatch/uf report# (b)(4).A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned.No device history record review was performed.No lot number was supplied by the customer.No sample available from the customer to investigate.Complaint not confirmed.Root cause unknown.Teleflex will continue to monitor feedback from the customers on issues related to humidifier burst and spraying water on patient.

Event Description

The customer alleges that the oxygen was just turned on and within a few minutes the flow rate was increased to 10l/min as the patient had just desaturated.The humidifier popped/burst, spraying water in the room and over the patient.The humidifier was connected to oxygen and nasal cannula.The patient was dying of cancer and was receiving only palliative care at the time of the incident.The patient expired a few hours later.

• Brand Name: HUDSON AQUAPAK 301 SW 340 ML
• Type of Device: RESPIRATORY GAS HUMIDIFIER
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 900 west university dr.; arlington heights IL 60004
• Manufacturer Contact: margie burton, rn ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 5637865
• MDR Text Key: 44673843
• Report Number: 1417411-2016-00062
• 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: health professional,other,use
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 003-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/12/2016
• Initial Date FDA Received: 05/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 30 YR