MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON CONCHA COLUMN SHELFPAK, PEDIATRIC; RESPIRATORY GAS HUMIDIFIER

Catalog Number 382-30

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Aspiration/Inhalation (1725); No Consequences Or Impact To Patient (2199)

Event Date 08/03/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A device history record (dhr) review could not be performed as the lot number reported by the customer was not a valid lot number.The sample is not available for investigation.Based on the customer complaint description, the concha product involved was an ip-5039 (b)(4).This product is not designed to be used in high flow nasal cannula therapy.The correct product is the concha smart column that is included in the comfort flo kit.The pediatric columns when working properly will flood when used incorrectly for high flow nasal cannula therapy.

Event Description

The customer alleges that the infant had been intubated and was assisted humid ventilation.At some point clinicians noticed water bubbling out of the top of the column, running down the breathing circuit and into the et tube and eventually into the infant's lungs.The infant had to be treated for water inhalation to the lungs, but no harmful, lasting effects were reported.

• Brand Name: HUDSON CONCHA COLUMN SHELFPAK, PEDIATRIC
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 5896472
• MDR Text Key: 52764238
• Report Number: 1417411-2016-00115
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/03/2016

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 Catalogue Number: 382-30
• Device Lot Number: 74G44
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/03/2016
• Initial Date FDA Received: 08/23/2016
• 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 Outcome(s): Required Intervention
• Patient Age: 14 MO