MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE, INC. FISHER PAYKEL HUMIDIFIER CHAMBER; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Model Number MR850

Device Problem Improper Flow or Infusion (2954)

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

Event Type  malfunction  

Event Description

"xxxx" has successfully removed 1l sterile water bags from use outside the pharmacy, primarily replaced with spikable bottles.However, we've gotten a concern from respiratory therapy about the use of the 1l bottles and the recommendation from the device manufacturer was to switch back to 1l sw bags.We are working with rt to determine if there is a human factor involved in the concern they have brought up (not opening valves), but wanted to share in case other organizations have the same barriers.Below are excerpts from the report i received from rt: we are having multiple issues with the sterile water failing to flow in to the fisher paykel (model number mr850) humidifier chamber.The water bottle is a vyaire, airlife sterile water for inhalation, usp.Reference number is chb0010.What we are experiencing is problems with the water failing to draining into the chamber.This happens randomly and does appear not related to the vent valve on the tubing being closed.Rt staff has reached out to our f&p clinical specialist for assistance.The only solution that they have is to switch back to the 1l bags of water.I do know that the change was brought about for patient safety.However, having a patient plug their ett due to inadequate humidification is also a patient safety issue.We have a conversation ongoing between different sites.One recommendation brought up was "if staff decides to place the water bottle in the basket instead of hanging it on the vent pole, there is no true gravity, and water flow will be dismal." we are providing additional education to staff on bottle placement and valves.Error occurred; medication did not reach pt.(b)(4).Submission id: (b)(4).

• Brand Name: FISHER PAYKEL HUMIDIFIER CHAMBER
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE, INC.
• MDR Report Key: 15380733
• MDR Text Key: 299703148
• Report Number: MW5111934
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/07/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: MR850
• Patient Sequence Number: 1
• Treatment: STERILE WATER FOR INJECTION IV BAG 1 LITER; STERILE WATER FOR INJECTION SPIKABLE BOTTLES