MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON AQUATHERM III,ELECTRONIC HEATER; HEATER, BREATHING SYSTEM W/WO

Catalog Number 050-14

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/30/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.Without the device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

Customer complaint alleges the product was leaking water during use and upon inspection the rubber washer was damaged.No patient harm was reported.The device was immediately replaced with another heater.

Manufacturer Narrative

Qn#(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the gasket was broken/damaged.Functional testing was performed and the unit passed all tests.A device history record review was performed and no relevant findings were identified.The issue reported in the complaint could not be attributed to a manufacturing root cause as the unit passed all the electrical testing.All units are electrically tested after the packaging process, thus any defects would be detected prior to release from the manufacturing facility.It was determined that the gasket was damaged by frequent use.

Event Description

Customer complaint alleges the product was leaking water during use and upon inspection the rubber washer was damaged.No patient harm was reported.The device was immediately replaced with another heater.

• Brand Name: HUDSON AQUATHERM III,ELECTRONIC HEATER
• Type of Device: HEATER, BREATHING SYSTEM W/WO
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 9586685
• MDR Text Key: 175840770
• Report Number: 3003898360-2020-00113
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 050-14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• Date Manufacturer Received: 02/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.