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

Model Number MR290V

Device Problems Unintended Ejection (1234); Device Handling Problem (3265)

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

Event Date 09/18/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint device was recently received at fisher & paykel healthcare for evaluation.We are in process to determine if f&p's product caused or contributed to the reported event.We will provide a follow up report upon completion of our investigation.

Event Description

A hospital in the (b)(6) reported via a fisher & paykel healthcare field representative that a mr290v vented humidification chamber was "leaking and bubbling around the base".No patient consequence was reported.

Event Description

A hospital in the uk reported via a fisher & paykel healthcare field representative that a mr290v vented humidification chamber was "leaking and bubbling around the base".No patient consequence was reported.

Manufacturer Narrative

(b)(4).Method: the complaint mr290 chamber was returned to fisher & paykel healthcare in new zealand.The chamber was visually inspected and a fourier transform infrared spectroscopy (ftir) was conducted.Results: visual inspection revealed that white residue was present on the inside and outside of the chamber.Clear residue was found inside between one of the ports and the base.The flow marks in the residue show that the residue did flow from the port towards the base of the chamber.Bubbles of white residue was found on the inside and outside of the chamber dome around the base.Samples of the white residue were removed from the outside of the chamber for ftir analysis.Examination of the chamber where the external residue sample was removed showed that there were holes in the chamber wall.Ftir analysis of the white residue revealed that the white residue was identified as a 95% match for acrylic (poly-methyl methacrylate) and polystyrene.Conclusion: the f&p circuit and f&p mr290 chamber do not contain acrylic plastic.Acrylic (pmma) plastic is highly susceptible to attack by halogenated solvents.The chemical makeup of the residue, the presence of white material on the chamber inlet and at the water line of the chamber, as well as the formation of holes in the chamber lead to the conclusion that isoflurane had dissolved an acrylic part attached to the chamber, with the dissolved acrylic plastic dripping into the chamber.As the isoflurane would be partially stabilised by being contained in dissolved plastic it would be able to attack the chamber.Holes in the dome were found in two more areas where residue bubbles were opened or removed.The investigation findings were shared with the customer.Every mr290 chamber is pressure tested following the manufacturing process to check for any leaks present in the chamber dome due to cracks or 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 mr290v chamber would have met the required specification at the time of production.The user instruction that accompany the f&p mr290v vented autofeed humidification chamber shows in pictorial form the correct setup of the mr290 chamber with a water bag.The water bag on the picture has the label "h2o" on it, which is the chemical name for water.The user instruction also states in the 'attention section': "use usp sterile water for inhalation or equivalent".The user instructions only uses the word "water" when referring to the used liquid for the mr290 chamber (for example, "do not fill the chamber with water in excess of 37c", "do not use the chamber if the water level rises above the maximum water level line", etc.).In addition, the user instruction of the f&p mr290v humidification chamber state the following: - "do not soak, wash, sterilize, or reuse this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers.

• 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: 7972831
• MDR Text Key: 124564832
• Report Number: 9611451-2018-00888
• 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: 09/18/2018

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: MR290V
• Device Catalogue Number: MR290V
• Device Lot Number: 171129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2018
• Initial Date Manufacturer Received: 09/18/2018
• Initial Date FDA Received: 10/17/2018
• Supplement Dates Manufacturer Received: 09/18/2018
• Supplement Dates FDA Received: 11/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DRAGER V500 VENTILATOR; DRAGER V500 VENTILATOR; F&P 900MR800 HEATERWIRE ADAPTOR; F&P 900MR800 HEATERWIRE ADAPTOR; F&P 900MR869 TEMPERATURE PROBE; F&P 900MR869 TEMPERATURE PROBE; F&P MR850 HUMIDIFIER; F&P MR850 HUMIDIFIER; PAEDIATRIC CIRCUIT; PAEDIATRIC CIRCUIT; PAEDIATRIC CIRCUIT; PAEDIATRIC CIRCUIT