MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD MANUAL FILL INFANT/PAEDIATRIC HUMIDIFICATION CHAMBER; BTT

Model Number MR225

Device Problems Filling Problem (1233); Protective Measures Problem (3015); Unexpected Shutdown (4019)

Patient Problems Bradycardia (1751); Cardiac Arrest (1762); Low Oxygen Saturation (2477)

Event Date 12/18/2020

Event Type  Death  

Manufacturer Narrative

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

Event Description

A healthcare facility in (b)(6) reported that the water was above the maximum fill level line of the mr225 manual fill humidification chamber.It was reported that the excess water in the mr225 chamber was emptied and replaced.It was then reported that the ventilator stopped working and alarmed with high pressure.Further to this, it was reported that the non-f&p nitric oxide (no) delivery sokinox machine required replacement and water in the rt265 infant evaqua2 breathing circuit required emptying.The patient was provided manual ventilation with the neopuff resuscitator whilst the setup was adjusted.It was further reported that the patient had previously suffered a cardiopulmonary arrest, however the timing of this is unclear.The patient initially recovered, however suffered a cardiopulmonary arrest a few of hours later, leading to the patient's demise.

Manufacturer Narrative

(b)(4).Mr225 is a manually filled chamber and the water level is to be controlled by the operator or user through the use of a water feed set tube and clamp.A photograph of the equipment set-up was also provided to us.Visual inspection of the provided photograph observed that a non-f&p water feed set tube and clamp were used with the subject mr225 manual fill humidification chamber.The user instructions that accompany the mr225 humidification chamber specify in the warnings section: do not fill the chamber above the maximum fill level line.Liquid could enter the breathing circuit if the chamber is overfilled.Ensure that the water level in the chamber is periodically monitored.Refill when necessary.Ensure the water bag is placed below the level of the humidifier after the chamber has been filled.Ensure the humidifier is not tilted.Tilting the humidifier may result in water entering the breathing circuit.Ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient.In addition, the user instructions of mr850 respiratory humidifier warns the following ensure that appropriate ventilator and/or patient monitor alarms are set, connections are secure and a leak test is completed before use.When mounting a humidifier adjacent to a patient ensure that the humidifier is always securely mounted and positioned lower than the patient.The user instructions that accompanies the rt265 dual-heated infant breathing circuit warns to ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient.Check breathing circuits for condensation every 6 hours and drain if required.

Event Description

A healthcare facility in (b)(6) reported that the water was above the maximum fill level line of the mr225 manual fill humidification chamber.It was reported that the excess water in the mr225 chamber was emptied and replaced.It was then reported that the ventilator stopped working and alarmed with high pressure.Further to this, it was reported that the non-f&p nitric oxide (no) delivery sokinox machine required replacement and the water in the rt265 infant evaqua2 breathing circuit required emptying.The patient was provided manual ventilation with the neopuff resuscitator whilst the setup was adjusted.It was further clarified that the patient had bradycardia, was desaturating and suffered a cardiopulmonary arrest.The patient initially recovered, however suffered a cardiopulmonary arrest a few of hours later, leading to the patient's demise.

• Brand Name: MANUAL FILL INFANT/PAEDIATRIC HUMIDIFICATION CHAMBER
• Type of Device: BTT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 11197788
• MDR Text Key: 227718418
• Report Number: 9611451-2021-00063
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: K913367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MR225
• Device Catalogue Number: MR225
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Date Manufacturer Received: 02/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2019
• 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): Death
• Patient Age: 4 DA