MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD VENTED HUMIDIFICATION CHAMBER; AUTOFEED CHAMBER

Model Number MR290VX

Device Problem Leak/Splash (1354)

Patient Problem Epistaxis (4458)

Event Date 09/23/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently in the process of finalising our investigation.We will provide a follow up report upon completion of our investigation.

Event Description

A healthcare facility in vastras reported, via a fisher & paykel healthcare (f&p) field representative, that a mr290vx vented autofeed humidification chamber was found to be leaking after one day of use.It was discovered the following day that the patient had dried blood in their nose.Inspection of the chamber identified a leak at the connection of the chamber dome and base.No further patient consequence was reported.

Event Description

A healthcare facility in sweden reported, via a fisher & paykel healthcare (f&p) field representative, that a mr290vx vented autofeed humidification chamber was found to be leaking after one day of use.It was discovered the following day that the patient had dried blood in their nose.Inspection of the chamber identified a leak at the connection of the chamber dome and base.No further patient consequence was reported.

Manufacturer Narrative

(b)(4).Method: the complaint mr290vx vented autofeed humidification chamber was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is therefore based on the information provided by the customer, previous investigations of similar complaints and our knowledge of the product.Results: the customer reported that a mr290vx vented autofeed humidification chamber was leaking during patient use.It was reported that the leak was between the chamber dome and base and that the customer had used nebulised drugs with sodium chloride with the complaint chamber.Conclusion: without the return of the complaint device, we are unable to determine the cause of the reported event.However, it is likely due to the use of sodium chloride.Sodium chloride is highly corrosive to aluminium.The presence of this solution could cause degradation of the aluminium plate over time.Every mr290vx chamber is pressure tested following the manufacturing process to check for any leaks present in the chamber due to cracks and other causes.Any chamber which fails this test is rejected.In addition, the pressure test is followed by a visual inspection of each chamber.No cracks in the chamber dome are acceptable.Any chamber that fails this inspection is rejected.The subject mr290vx chamber would have met the required specification at the time of production.Our user instructions that accompany the mr290vx vented autofeed humidification chamber state the following: "do not soak, wash, sterilize, or reuse this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers." "ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient." "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient." "use of the mr290 above the maximum operating pressure may lead to cracking, water leakage and, on rare occasions could lead to a loss of ventilation pressure.".

• Brand Name: VENTED HUMIDIFICATION CHAMBER
• Type of Device: AUTOFEED CHAMBER
• 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 ; 17400 laguna canyon road; suite #300; irvine, CA 92618 ; 9494534000
• MDR Report Key: 15678008
• MDR Text Key: 302501315
• Report Number: 9611451-2022-01008
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K934140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MR290VX
• Device Catalogue Number: MR290VX
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/29/2022
• Initial Date FDA Received: 10/26/2022
• Supplement Dates Manufacturer Received: 11/28/2022
• Supplement Dates FDA Received: 11/30/2022
• 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: AEROGEN SOLO NEBULIZER.; AEROGEN SOLO NEBULIZER.; EVATHERM BREATHING CIRCUIT.; EVATHERM BREATHING CIRCUIT.; F&P MR810 RESPIRATORY HUMIDIFIER.; F&P MR810 RESPIRATORY HUMIDIFIER.; PHILIPS WISP PEDIATRIC MASK.; PHILIPS WISP PEDIATRIC MASK.; RESMED ASTRAL 100 VENTILATOR.; RESMED ASTRAL 100 VENTILATOR.
• Patient Age: 9 MO