MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD ADULT NASAL INTERFACE; CAT

Model Number OPT

Device Problem Leak/Splash (1354)

Patient Problem Pulmonary Edema (2020)

Event Date 12/27/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).We are currently in the process of obtaining more information from the original complainant about the status of the complaint optiflow device.We will provide a follow-up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported via the fda that an optiflow device was "noted with water spewing in patient facemask." the model of the opt cannula was not provided.It was also stated that the patient was intubated because of the water spewing and the doctor believes that this issue may have contributed to the patient's pulmonary edema.No further patient consequences were reported.

Manufacturer Narrative

(b)(4).Following the report of the incident (via the medwatch report received from fda), we attempted to retrieve the complaint cannula, photos and further information from the hospital.As our first awareness data for this complaint was over one month following the reported event date, the contact person at the hospital was not able to collect the complaint device or provide many details surrounding the event.Method: the complaint optxxx nasal cannula (specific model and size unknown) was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the initial medwatch report, information provided by the hospital, and our knowledge of the product.Conclusion: without the complaint device we cannot confirm exactly what may have caused the excessive condensation.However, the customer stated that an rt219 breathing circuit was being used in conjunction with the optxxx cannula, with the f&p mr850 respiratory humidifier operating in "invasive" mode.The user instructions that accompany the rt219 state: " the rt219 circuit indicated for use with patients requiring bi-level or cpap therapy." in addition, the setup instructions that accompany the mr850 respiratory humidifier indicate the appropriate breathing circuit kit (rt202) to be used with optiflow therapy.It is also noted in the setup instructions that the rt219 circuit kit is indicated for use with bi-level or cpap therapy, and should only be used with the mr850 operating in "non-invasive" mode.Therefore, based on the information provided, the excessive condensation reported by the customer in this event was most likely due to improper use/setup of the device.The user instructions which accompany the opt9xx nasal cannula state the following: "- setup: mr850 humidifier in invasive mode, rt series kit with 22 mm heated inspiratory tube and chamber (e.G.Rt202)" "- flow range: < 60 l/min" "- appropriate patient monitoring must be used at all times.Failure to monitor the patient may result in loss of therapy, serious injury or death." "- failure to use the set-up described above can compromise the performance and affect patient safety." "- check for condensate regularly.Drain as required.".

Event Description

A healthcare facility in north carolina reported via the fda that an optiflow device was "noted with water spewing in patient facemask." the model of the opt cannula was not provided.It was also stated that the patient was intubated because of the water spewing and the doctor believes that this issue may have contributed to the patient's pulmonary edema.It was also reported that the patient had since been extubated.No further patient consequences or information was reported.

• Brand Name: ADULT NASAL INTERFACE
• Type of Device: CAT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 8397757
• MDR Text Key: 138070755
• Report Number: 9611451-2019-00208
• Device Sequence Number: 1
• Product Code: CAT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: OPT
• Device Catalogue Number: OPT
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MR850 RESPIRATORY HUMIDIFIER; RT219 BREATHING CIRCUIT
• Patient Outcome(s): Life Threatening