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

Model Number MR290V

Device Problems Corroded (1131); Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint device mr290v vented autofeed humidification chambers were not returned to fisher & paykel healthcare (f&p) in (b)(4) for evaluation.Our investigation is based on the information and photographs provided by the customer, previous investigations of similar complaints, and our knowledge of the product.Results: visual inspection of the photographs confirmed holes were found on the aluminium base of the chamber.White-coloured deposits and black-coloured marks were observed on the aluminium base.It was reported by the healthcare facility that 1.4% sodium bicarbonate solutions were unintentionally used with the mr290v vented autofeed humidification chambers.Conclusion: based on the information provided by the customer and previous investigations of similar complaints, the cause of the degradation is due the presence of sodium bicarbonate solution in the mr290v chambers.Sodium salt is highly corrosive to aluminium.The presence of this solution could cause degradation of the aluminium plate over time.Every mr290v 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.".

Event Description

A healthcare facility in (b)(6) reported that two mr290v vented autofeed humidification chambers base plates had pin-holes and water was leaking through the pin-holes.The hospital further reported that 1.4% sodium bicarbonate solution was used with the chambers.There were no reported patient consequences.

• 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
• MDR Report Key: 11449313
• MDR Text Key: 244154039
• Report Number: 9611451-2021-00266
• 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: foreign,user facility
• Type of Report: Initial
• Report Date: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 02/08/2021
• 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