MAUDE Adverse Event Report: VENTED AUTOFEED HUMIDIFICATION CHAMBER; BTT

Model Number MR290V

Device Problems Filling Problem (1233); Short Fill (1575)

Patient Problems Obstruction/Occlusion (2422); Low Oxygen Saturation (2477)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Fisher & paykel healthcare (f&p) are currently in the process of retrieving further information from the customer.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 mr290v vented autofeed humidification chambers were not appropriately filling with water.It was further reported that patients developed mucous plugs and desaturated, requiring medical intervention.No further patient consequences were reported.

Event Description

A healthcare facility in france reported, via a fisher & paykel healthcare (f&p) field representative, that some mr290v vented autofeed humidification chambers were not appropriately filling with water.It was further reported that patients developed mucous plugs, requiring medical intervention.One of these patients desaturated to 70% spo2 and required fibroscopy, re-intubation and respiratory re-adaptation.There were no further reported patient consequences.

Manufacturer Narrative

(b)(4).Method: an f&p field representative visited the hospital to request the return of the subject mr290v vented autofeed humidification chambers (mr290v chambers), gather further information regarding the sequence of events and patient consequence, and observe the reported device set-up.The devices were not available to return for investigation; therefore, our investigation is based on the information provided by the customer and observations by the f&p field representative.Results: the customer reported that the mr290v chambers were not appropriately filling with water.The f&p field representative observed a typical set-up of the mr290v chambers at the hospital.It was noted that in some cases, the water bag was positioned less than 50cm above the humidifiers.Conclusion: without the complaint devices, we are unable to confirm the reported events.Further training on device set-up was provided.Every mr290v chamber is pressure tested following the manufacturing process to check for any leaks present in the feedset.Our user instructions state the following: check all connections are tight before use.The water source must be at least 50cm higher than the chamber.When mounting a humidifier adjacent to a patient, ensure that the humidifier is always positioned lower than the patient.Ensure there is a water supply connected to the chamber and that water is present within the chamber.Ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient.Use of the mr290v above the maximum operating pressure may lead to cracking, water leakage and, or rare occasions, could lead to a loss of ventilation pressure.Appropriate patient monitoring (e.G.Oxygen saturation) must be used at all times.Failure to monitor the patient (e.G.In the event of an interruption to gas flow) may result in serious harm or death.

• Brand Name: VENTED AUTOFEED HUMIDIFICATION CHAMBER
• Type of Device: BTT
• MDR Report Key: 11593064
• MDR Text Key: 243106982
• Report Number: 9611451-2021-00334
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: K934140
• 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: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MR290V
• Device Catalogue Number: MR290V
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/20/2021
• 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
• Treatment: F&P MR850 RESPIRATORY HUMIDIFIERS; F&P RT380 ADULT DUAL HEATED EVAQUA2 CIRCUIT; F&P RT380 ADULT DUAL HEATED EVAQUA2 CIRCUITS; VENTILATORS: GE CARESCPAE AND HAMITON C6
• Patient Outcome(s): Required Intervention