MAUDE Adverse Event Report: HUDSON UNIVERSAL CONCHA COLUMN; HUMIDIFIER, RESPIRATORY GAS, (

Model Number IPN913861

Device Problem Improper Flow or Infusion (2954)

Patient Problem Ventilator Dependent (2395)

Event Date 03/30/2021

Event Type  Injury  

Manufacturer Narrative

Qn#(b)(4).

Event Description

It was reported "on march 39th, a 2 week old on ventilator, in prvc setting, was not getting volume due to column.The vent was reading delivered volumes, but due to the column, the patient lungs were not.The patient heart rate increased and became tachypneic in noticeable work of breathing.The patient received an emergency bronchoscopy, fluid bolus and almost arrested.When the therapist noticed they were using a smart column.When the column was changed, they were able to ventilate the infant to a stable condition.No death occurred.Patient condition today is stable".It was reported that device was replaced.

Event Description

It was reported "on march 39th, a 2 week old on ventilator, in prvc setting, was not getting volume due to column.The vent was reading delivered volumes, but due to the column, the patient lungs were not.The patient heart rate increased and became tachypneic in noticeable work of breathing.The patient received an emergency bronchoscopy, fluid bolus and almost arrested.When the therapist noticed they were using a smart column.When the column was changed, they were able to ventilate the infant to a stable condition.No death occurred.Patient condition today is stable".It was reported that device was replaced.

Manufacturer Narrative

Qn# (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.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.

• Brand Name: HUDSON UNIVERSAL CONCHA COLUMN
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (
• MDR Report Key: 11740120
• MDR Text Key: 252013905
• Report Number: 3004365956-2021-00178
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 14026704660671
• UDI-Public: 14026704660671
• Combination Product (y/n): N
• PMA/PMN Number: K760866
• 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: 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: IPN913861
• Device Catalogue Number: 382-10
• Device Lot Number: 74E2001428
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/30/2021
• 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
• Treatment: VENTILATOR; VENTILATOR
• Patient Outcome(s): Life Threatening; Required Intervention