MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD RESPIRATORY HUMIDIFIER; BTT

Model Number F&P950

Device Problem Misconnection (1399)

Patient Problems Patient Problem/Medical Problem (2688); No Code Available (3191)

Event Date 12/14/2018

Event Type  Injury  

Manufacturer Narrative

Ps299597 the f&p 950 respiratory humidifier is not currently available for sale in the united states.The f&p mr850 respiratory humidifier is an equivalent device currently on the market in the us.At the time of initial reporting, the hospital was contacted in an effort to obtain the complaint f&p 950 respiratory humidifier for investigation.The hospital advised that the subject f&p 950 respiratory humidifier was not available and had been returned to service at the hospital.We also requested to download the f&p 950 device log for analysis, however we were informed that it was not possible to locate the device for log download.Methods: a visual inspection of the photograph provided by the customer was performed, in conjunction with a review of the information provided by the hospital and our knowledge of the product.Results: visual inspection of the customer photograph revealed that the f&p 950 respiratory humidifier had been connected in reverse to the ventilator.Conclusion: based on visual inspection of the photograph and information provided by the customer, a use error occurred which resulted in the gas flow from the ventilator flowing in a reversed direction through the f&p 950 respiratory humidifier.After a prolonged period of time (5 days), this resulted in a patient experiencing a bronchiole plug which required removal.The patient fully recovered after the event.The f&p 950 humidifier complies to iso 5356-2:2015 (anaesthetic and respiratory connectors, cones and sockets - part 1).Our user instructions that accompany the f&p 950 adult ventilator circuit kit illustrate step-by-step instructive diagrams of the correct set up of the breathing circuit limbs and labeling of the ventilator inspiratory and expiratory ports.As an additional feature, the f&p 950 adult ventilator circuits have been designed with an inspiratory limb, expiratory limb, and dryline that are colour-coded to assist with proper set up.Fisher & paykel healthcare also conducted a one-week specialised product training with the installation of the f&p 950 respiratory humidifier at this hospital during the week of (b)(6) 2018.Background: with the connection of breathing circuits to ventilators there is the potential for the gas connections to be reversed which result in the gas flowing through the breathing circuit in a reversed direction.For adult ventilators, the primary cause of this is the two ventilator connections being identical 22 mm male iso connections and, in many cases, identical in colour.Respiratory humidifiers typically reside as part of the breathing circuit and are subject to this reversed flow condition.Technical and functional limitations of these devices result in a limited ability to detect the flow orientation.Breathing circuits and, by default, respiratory humidifiers, are required to comply with international standard iso 5356-2:2015 (anaesthetic and respiratory connectors, cones and sockets - part 1).As such, prevention of reversed connections is highly dependent on the setup of the humidification device within the system.

Event Description

A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that the f&p 950 respiratory humidifier did not generate an alarm when configured with a ventilator such that the gas flowed in a reverse direction through the humidifier.No patient consequence was originally reported.Directly after the event, the f&p territory manager visited the hospital to provide additional training and support regarding equipment setup.At this time, additional information was provided that the patient involved had been ventilated for 5 days, which had resulted in their airway secretions drying, requiring a bronchoscopy and surgical intervention to remove a bronchiole plug.

• Brand Name: RESPIRATORY HUMIDIFIER
• Type of Device: BTT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: faranak gomarooni ; 173 technology suite drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 8423450
• MDR Text Key: 138891956
• Report Number: 9611451-2019-00234
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: F&P950
• Device Catalogue Number: F&P950
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: DRAGER V500 VENTILATOR
• Patient Outcome(s): Required Intervention