MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON AQUAPAK 340 SW,340 ML W/040 ADAPTOR,FRE; HUMIDIFIER

Catalog Number 003-40F

Device Problem Leak/Splash (1354)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 05/26/2015

Event Type  malfunction  

Event Description

The customer alleges an air leak at the level of the adaptor and the bottle.Clinical consequence: desaturation of the patient.Intervention: the device was replaced.

Manufacturer Narrative

(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.A device history review was not conducted since no lot number was supplied by the customer.Complaint not confirmed at this time.No sample available from the customer to investigate.Teleflex will continue to monitor feedback from the customers on issues related to air leaks at the level of the adaptor found at inspection or prior to use.

Manufacturer Narrative

(b)(4).Two photos were received from the customer for evaluation.Both photos show the connection of the flowmeter, humidifier adaptor and water bottle attached to the oxygen source.While the set up looks typical, no details regarding the leak could be discerned from the pictures.Samples are needed to determine the root cause.If the sample is returned, a follow-up report will be submitted with investigation results.

Event Description

The customer alleges an air leak at the level of the adaptor and the bottle.Clinical consequence: desaturation of the patient.Intervention: the device was replaced.

• Brand Name: HUDSON AQUAPAK 340 SW,340 ML W/040 ADAPTOR,FRE
• Type of Device: 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 4851496
• MDR Text Key: 21181001
• Report Number: 1417411-2015-00107
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 003-40F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/28/2015
• 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 Outcome(s): Required Intervention