MAUDE Adverse Event Report: RESPIRATORY HUMIDIFIER; BTT

Model Number F&P 950

Device Problems Misconnection (1399); Obstruction of Flow (2423); Appropriate Term/Code Not Available (3191)

Patient Problems Obstruction/Occlusion (2422); Patient Problem/Medical Problem (2688)

Event Date 12/26/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.We are in the process of investigation to determine if fisher & paykel healthcare's product caused or contributed to the reported event.We will provide a follow up report upon the completion of our investigation.

Event Description

A healthcare facility in australia reported via a fisher & paykel healthcare (f&p) field representative that a f&p 950 respiratory humidifier was involved in a patient incident of endotracheal tube replacement due to obstruction by dried secretion.Further information was received that the patient had been extubated with no further consequences.

Manufacturer Narrative

(b)(4).Method: the complaint device was not returned to fisher & paykel healthcare (f&p) for evaluation.The device log file was retrieved and provided to f&p for investigation.This investigation is based on photographs, information provided by the customer and the device log file.The complaint f&p 950 respiratory humidifier was placed back into service by the hospital.Results: visual inspection of the photograph revealed that the f&p 950 respiratory humidifier had been incorrectly connected to the ventilator.The inspiratory breathing circuit and expiratory breathing circuit connections at the ventilator were connected the wrong way around.Review of the device log file revealed that the subject f&p 950 respiratory humidifier was in continuous use after the reported event and was operating as expected.However, it was not possible to review the data from the date of reported event as the device log file has maximum storage capability of 24 hours.Conclusion: the customer reported that the patient incident was due to a user error whereby the inspiratory limb and expiratory limb were connected in reverse.This is evident through visual inspection of the photograph provided.The incorrect setup caused the delivery of dry medical gasses to the patient.After a prolonged period of time (24 hours), this resulted in the formation of dried secretions in the patient's airway, which required the emergency endotracheal tube to be replaced.The patient has fully recovered after the event.Respiratory humidifiers are part of the ventilation system which deliver medical gases to mechanically ventilated patients.The gas connection ports of the f&p 950 respiratory humidifier comply with the current ventilator standard iso 80601-2-12:2011 to enable gas connection between the systems.This standard specifies that both gas connection ports must be 22 mm male connections, which comply with iso 5356-1:2015 for medical tapers with which the f&p 950 respiratory humidifier complies with.The user instructions that accompany the f&p 950 respiratory humidifier breathing circuits provide step by step instructive diagrams of the correct setup.The inspiratory limb, dry line and the expiratory limb of the f&p 950 respiratory breathing circuits have different colours to identify the direction of flow.The colour of the breathing circuits is designed to differentiate the direction of the gas flow.Whilst there remains an element of user dependency for correct set up, prevention of reversed connections has been mitigated as much as possible whilst still complying to the standard to enable use across ventilation systems.

Event Description

A healthcare facility in new south wales reported via a fisher & paykel healthcare (f&p) field representative that a f&p 950 respiratory humidifier was involved in a patient incident where an endotracheal tube required replacement.It was reported that the patient's airway was obstructed or partially obstructed due to dried secretions.The hospital reported that the incident was related to a user error whereby the inspiratory limb and expiratory limb of the breathing circuit were connected to the ventilator in reverse.The f&p 950 respiratory humidifier operated for approximately (b)(4) hours in this configuration and it alarmed under this condition.Further information was received that the patient had been extubated with no further consequences.

• Brand Name: RESPIRATORY HUMIDIFIER
• Type of Device: BTT
• MDR Report Key: 9709784
• MDR Text Key: 183168754
• Report Number: 9611451-2020-00118
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: F&P 950
• Device Catalogue Number: F&P 950
• Device Lot Number: 2100062384
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2016
• 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: HAMILTON G5 VENTILATOR; HAMILTON G5 VENTILATOR
• Patient Outcome(s): Required Intervention