MAUDE Adverse Event Report: VENTED HUMIDIFICATION CHAMBER; AUTOFEED CHAMBER

Model Number MR290V

Device Problems Corroded (1131); Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/19/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).One of the complaint device mr290v humidification chamber is currently en-route to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow up report upon completion of our investigation.

Event Description

A healthcare facility in the (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that two mr290v vented autofeed humidification chamber base corroded while in use with flolan and nitric solution.There were reported patient consequences.

Event Description

A healthcare facility in the uk reported via a fisher & paykel healthcare (f&p) field representative that two mr290v vented autofeed humidification chamber base corroded while in use with flolan and nitric solution.There were reported patient consequences.

Manufacturer Narrative

(b)(4).D4 batch number updated.Method: one of the complaint device mr290v humidification chamber was received at fisher & paykel healthcare (f&p) in new zealand where it was visually inspected and analysed.Results: visual inspection revealed that the subject chamber was returned with a nebuliser (non f&p product) assembled on one of the inlet ports.Visual inspection confirmed that a hole was found on the base of the chamber located under the port with the nebuliser.Additionally, a stain was found on the inside of the chamber.Further analysis of the subject mr290 chamber base was conducted using a scanning electron microscope (sem), which revealed additional small holes in multiple areas of the subject mr290 chamber base.Additionally, evidence of a brown residue was found across the subject mr290 chamber base and on the sides of the large hole.Chemical analysis of the brown residue confirmed the presence of sodium carbonate and sodium chloride.Conclusion: based on the information provided by the customer and our investigation of the complaint device, the cause of the degradation is due the presence of flolan solution in the mr290 chamber.The solution containing sodium salt is highly corrosive to aluminium.The presence of this solution could cause degradation of the aluminium plate over time.Every mr290 chamber is pressure tested following the manufacturing process to check for any leaks present 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.The subject chamber would have met the required specification prior to distribution.Our user instructions that accompany the mr290v vented autofeed humidification chamber states the following: "do not soak, wash, sterilize, or reuse this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers." "use usp sterile water for inhalation or equivalent.".

• Brand Name: VENTED HUMIDIFICATION CHAMBER
• Type of Device: AUTOFEED CHAMBER
• MDR Report Key: 10081282
• MDR Text Key: 204049831
• Report Number: 9611451-2020-00490
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MR290V
• Device Catalogue Number: MR290V
• Device Lot Number: 190906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2020
• Date Manufacturer Received: 06/19/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2019
• 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
• Treatment: AEROGEN NEBULIZER ADAPTOR; AEROGEN NEBULIZER ADAPTOR; DRAEGER EVITA VENTILATOR; DRAEGER EVITA VENTILATOR; F&P RT380 ADULT BREATHING CIRCUIT; F&P RT380 ADULT BREATHING CIRCUIT