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

Model Number OPT944

Device Problems Disconnection (1171); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bradycardia (1751); Death (1802); Hypoxia (1918); Low Oxygen Saturation (2477)

Event Date 10/08/2020

Event Type  Death  

Manufacturer Narrative

(b)(4).The complaint opt944 optiflow adult nasal cannula is currently en route to fisher & paykel healthcare (f&p) (b)(6) 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 healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that while a patient with dementia was attempting to get out of bed, the tubing of the opt944 optiflow adult nasal cannula disconnected from the connector.The patient's heart rate dropped and the patient desaturated.The hospital further reported that the patient would pull the cannula and would often try to remove the cannula.It was further reported that the patient deceased after experiencing a hypoxic and cardiac event, however there is no indication from the healthcare facility of any causal relationship between the patient death and the reported event.It was noted that the patient had do not resuscitate directives.

Event Description

A healthcare facility in idaho reported via a fisher & paykel healthcare (f&p) field representative that while a patient with dementia was attempting to get out of bed, the tubing of the opt944 optiflow + adult nasal cannula disconnected from the connector.The patient's heart rate dropped and the patient desaturated.The hospital further reported that the patient would pull the cannula and would often try to remove the cannula.It was further reported that the patient deceased after experiencing a hypoxic and cardiac event, however there is no indication from the healthcare facility of any causal relationship between the patient death and the reported event.It was noted that the patient had do not resuscitate directives.

Manufacturer Narrative

(b)(4).Section d2 common device name has been corrected from cat to btt.The opt944 interface is used to deliver humidified oxygen to patients.The opt944 consists of a lightweight delivery tube which is connected to a rigid plastic base and soft nasal prongs (nasal interface).The interface is held in place by a head strap and also includes a lanyard which is placed around the patient's neck or attached to the patient's clothing or bedding to remove the load of the breathing circuit from the patient's nares.The customer provided additional information regarding the patient's medical history relevant to this event.The patient was an 88 year old male who presented to the emergency department with nausea, vomiting and acute cholecystitis.The patient was reported to have an aspiration event on (b)(6) where his minimal oxygen requirement had worsened to 5l.He was found to have bilateral pneumonia on routine imaging.The patient had worsening oxygen demands over subsequent days.On (b)(6), he was transitioned to the opt944 nasal cannula and was maintaining 95% spo2 on 60l, 100% fio2.The patient had periods of discomfort with the nasal cannula.The patient also had dementia.Method: the complaint opt944 optiflow adult nasal cannula was received at fisher & paykel healthcare (f&p) in new zealand for investigation where it was visually inspected.Result: visual inspection of the complaint opt944 revealed that the tubing was detached from the connector.The tubing was found slightly stretched at the connector and at the manifold end which indicates that pulling had occurred at both ends.When pull tested, the tubing did not disconnect from the swivel or unravel.Conclusion: we are unable to determine what caused the reported fault, however it was most likely pulled by the customer which is consistent with the information provided by the customer where they stated that the patient would often pull on the cannula.It was further reported that the patient deceased after experiencing a hypoxic and cardiac event, however there is no indication from the healthcare facility of any causal relationship between the patient death and the reported event.It was noted that the patient had do not resuscitate directive, which is a medical order written by a doctor to instruct health care providers not to perform cardiopulmonary resuscitation (cpr) if the patient's heart stops beating and/or not to intubate if a patient's breathing stops.All optiflow interfaces are inspected during production for visual defects including cracks, tears, inclusions, discoloration and stretching or deformation.Any product that fails the visual inspection is disposed of or reprocessed.The subject cannula would have met the specification at the time of production.The setup instructions in the user instructions which accompany the opt944 optiflow + adult nasal cannula include the following steps: "ensure head strap clip is attached, to prevent cannula from being pulled out of the nares." "cannula can become unattached if not used with the head strap clip." "attach tubing clip to clothing/bedding to prevent cannula from pulling off face." the user instructions also contain the following warnings/cautions: "appropriate patient monitoring must be used at all times.Failure to monitor the patient may result in loss of therapy, serious injury or death." "do not crush or stretch tube, to prevent loss of therapy." "failure to use the set-up described above can compromise performance and affect patient safety.".

• Brand Name: ADULT NASAL INTERFACE
• Type of Device: BTT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 10806422
• MDR Text Key: 215263572
• Report Number: 9611451-2020-00964
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: K162553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: OPT944
• Device Catalogue Number: OPT944
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2021
• Date Manufacturer Received: 03/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: F&P 900PT561 TUBE AND CHAMBER KIT.; F&P 900PT561 TUBE AND CHAMBER KIT.; F&P AIRVO 2 HUMIDIFIER.; F&P AIRVO 2 HUMIDIFIER.
• Patient Outcome(s): Death; Other
• Patient Age: 88 YR