MAUDE Adverse Event Report: RESPIRATORY HUMIDIFIER; BTT

Model Number F&P 950

Device Problems Misconnection (1399); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problems Bradycardia (1751); Cardiac Arrest (1762); Obstruction/Occlusion (2422); Low Oxygen Saturation (2477)

Event Date 11/06/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The f&p 950 respiratory humidifier is not currently available for sale in the united states of america (usa) but it is similar to a product which is sold in the usa.The 510(k) for that product is k110019.We are currently in the process of obtaining further information to determine f&p's involvement in the reported event.We will provide a follow up report upon the completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported, via a fisher & paykel healthcare (f&p) field representative, that a patient desatruated due to an obstruction in the endotracheal (et) tube while using an f&p 950 respiratory humidifier.It was further clarified on 21 january 2021 that following the reported desaturation, the patient became bradycardic and presented with pea (pulseless electrical activity) arrest.The patient was manually ventilated while the et tube was replaced.The patient recovered to a stable condition in fifteen minutes.It was reported that the dryline and expiratory limbs of a 950a81 adult ventilator dual heated circuit kit were incorrectly connected in reverse at the ventilator end.The customer confirmed that the incorrect setup did not cause or contribute to the reported incident.There were no further patient consequences.

Manufacturer Narrative

(b)(4).The f&p 950 respiratory humidifier is not currently available for sale in the united states of america (usa) but it is similar to a product which is sold in the usa.The 510(k) for that product is k110019.Method: the complaint device was not returned to f&p for evaluation as there was no reported malfunction with the device.The device was placed back in service at the hospital after the reported event.No further information regarding the complaint device such as the device lot number and the device log were able to be provided by the hospital.This investigation is thus based on the information provided by the hospital and our knowledge of the product.Results: the hospital reported that while using a f&p 950 respiratory humidifier, the dryline and expiratory limbs of a 950a81 adult ventilator dual heated circuit kit were incorrectly connected in reverse at the ventilator end.Conclusion: the reported event was due to a user error whereby the dry line and expiratory limb were connected in reverse at the ventilator end.In this instance, the patient continued to receive gas flow; however, no humidity was provided.Respiratory humidifiers are part of the ventilation system which deliver medical gases to mechanically ventilated patients.As such, respiratory humidifiers are required to comply with the gas connection ports specified in the current ventilator standard iso 80601-2-12:2011 (essential performance for ventilators).This standard specifies both gas connection ports to be 22 mm male connections, which comply with iso 5356-1:2015 (beathing circuit conical connectors) for medical tapers.Due to this, the prevention of reversed connections is highly dependent upon the user.The risk control applied across all devices is by providing step-by-step instructive diagrams of the correct set up.The user instructions that accompany the f&p 950 respiratory humidifier breathing circuits provide step-by-step instructive diagrams on the correct set up of the breathing circuit limbs.The f&p 950 adult ventilator circuits have been designed with an inspiratory limb, expiratory limb, and dryline that have different colours to differentiate between the direction of gas flow.However, there remains an element of user dependency for correct set up by complying with the user instructions.The user instructions include the following warnings and cautions: - "appropriate patient monitoring (e.G.Oxygen saturation) must be used at all times." - "prolonged exposure to reduced humidity will result in patient harm including decreased mucociliary clearance" an f&p representative has provided further training to the hospital with regards to correct setup in accordance with our user instructions.

Event Description

A healthcare facility in australia reported, via a fisher & paykel healthcare (f&p) field representative, that a patient desaturated due to an obstruction in the endotracheal (et) tube while using a f&p 950 respiratory humidifier.It was further clarified on (b)(6) 2021 that following the reported desaturation, the patient became bradycardic and presented with pea (pulseless electrical activity) arrest.The patient was manually ventilated while the et tube was replaced.The patient recovered to a stable condition in fifteen minutes.It was reported that the dryline and expiratory limbs of a 950a81 adult ventilator dual heated circuit kit were incorrectly connected in reverse at the ventilator end.The customer confirmed that the incorrect setup did not cause or contribute to the reported incident.There were no further patient consequences.

• Brand Name: RESPIRATORY HUMIDIFIER
• Type of Device: BTT
• MDR Report Key: 11345773
• MDR Text Key: 232516648
• Report Number: 9611451-2021-00040
• 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: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/17/2021
• 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: 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT; 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT; DRAGER V500 VENTILATOR; DRAGER V500 VENTILATOR
• Patient Outcome(s): Required Intervention