MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® THERMOVENT® HEAT AND MOISTURE EXCHANGER; CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)

Catalog Number 100/570/022

Device Problem Obstruction of Flow (2423)

Patient Problem Low Oxygen Saturation (2477)

Event Date 12/13/2016

Event Type  malfunction  

Manufacturer Narrative

Three unused portex® thermovent® heat and moisture exchangers from the same lot as the reported event were returned for evaluation.Visual inspection found the devices within specifications.Functional testing involved a flow test and found the devices within specifications.Based on the evidence, the complaint was unable to be confirmed.There was no evidence found to suggest the event was caused from an intrinsic defect in the product.

Event Description

It was reported that a portex® thermovent® heat and moisture exchanger filter was obstructed when a patient underwent oxygen desaturation.The incident occurred in the "reanimation unit" while the patient was under a tracheotomy and had an "artificial nose".It was observed that the filter was obstructed due to the patient's secretions.The device was set on the patient on the day of the event at 8am and the obstruction was observed at 11am.The patient desaturated "about 10 points" and the patient had to be "reanimated".The device was removed and a new hme filter was placed, which returned the patient's oxygen saturation to normal at 92%.The patient was still hospitalized in the resuscitation unit.The event was considered resolved.

Manufacturer Narrative

A review of the device history record was performed, and no discrepancies were noted.Upon receipt of the returned product specimen for device evaluation, it was visually examined.One used tracheostomy tube was received.No anomalies defects were observed.Dimensional inspection found the device to be within manufacturing specification.The reported issue could not be confirmed.While no definitive root cause could be determined, this investigation revealed no intrinsic evidence to suggest a root cause related to manufacturing.

• Brand Name: PORTEX® THERMOVENT® HEAT AND MOISTURE EXCHANGER
• Type of Device: CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS HEALTHCARE MANUFACTURING SA DE CV; carretera miguel alemán km21.7; parque industrial; monterrey, apodaca nl CP 66 603; MX CP 66603
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6266757
• MDR Text Key: 65410143
• Report Number: 3012307300-2017-00182
• Device Sequence Number: 1
• Product Code: BYD
• 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,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2021
• Device Catalogue Number: 100/570/022
• Device Lot Number: 3279246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/22/2016
• Initial Date FDA Received: 01/20/2017
• Supplement Dates Manufacturer Received: 08/01/2017
• Supplement Dates FDA Received: 08/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Weight: 48