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

Model Number OPT944

Device Problems Break (1069); Detachment of Device or Device Component (2907); Material Twisted/Bent (2981); Material Split, Cut or Torn (4008)

Patient Problems Arrhythmia (1721); Low Oxygen Saturation (2477)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We have requested the subject opt944 optiflow + adult nasal cannula to be returned to f&p (b)(4) for investigation.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 the tubing of an opt944 optiflow + adult nasal cannula was found bent and damaged during use on a covid19 patient.It was also reported that the patient desaturated from 94% to 77% spo2 levels, experienced cardio-respiratory distress and arrhythmia.The patient was provided an alternative therapy while the cannula was replaced.No further patient consequences were reported.

Event Description

A healthcare facility in france reported via a fisher & paykel healthcare (f&p) field representative that the tubing of an opt944 optiflow + adult nasal cannula was found bent and damaged during use on a covid-19 patient.It was also reported that the patient desaturated from 94% to 77% spo2, experienced cardio-respiratory distress and arrhythmia.The patient was provided alternative therapy while the cannula was replaced.Further information was requested about the patient's condition after the reported event , and it was disclosed that the patient was intubated in the days following the incident and later deceased.The healthcare facility stated that the medical cause of death was severe hypoxia in the clinical context of a covid-19 infection.

Manufacturer Narrative

Ps375786, the opt944 optiflow + adult nasal cannula is an interface used to deliver humidified oxygen to patients and consists of a lightweight delivery tube connected to a rigid plastic base and soft nasal prongs (nasal interface).The interface is held in place by a head strap and features a head strap clip which works in tandem with the tubing clip (attaches to the patient's clothing/bedding) to support the weight of the circuit and prevent the cannula being dislodged.Method: the complaint opt944 optiflow + adult nasal cannula was returned to fisher & paykel healthcare (f&p) in new zealand for investigation, where it was visually inspected.Our investigation is based on the visual inspection of the returned subject opt944, information provided by the customer and our knowledge of the product.Results: visual inspection of the returned cannula revealed that the tubing was stretched and pulled apart in several areas.The three way connector was not returned with the subject opt944.The healthcare facility also reported that the patient pre-existing condition included covid-19 infection.Conclusion: we are unable to determine the cause of the reported damage to the subject opt944 optiflow + adult nasal cannula.However, the damage observed was likely caused by the tubing being pulled.Further information was requested about the patient's condition after the reported event, and it was disclosed that the patient was intubated in the days following the incident and later deceased.The healthcare facility stated that the medical cause of death was severe hypoxia in the clinical context of a covid-19 infection.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 rejected.The subject opt944 optiflow + adult nasal cannula would have met the required specifications at the time of production.The user instructions which accompany the opt944 optiflow + adult nasal cannula show in pictorial format the correct placement and fitting of the cannula and also warn: "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: NASAL INTERFACE
• Type of Device: BTT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: faranak gomarooni ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 12346153
• MDR Text Key: 268796603
• Report Number: 9611451-2021-00973
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K162553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 11/16/2021
• Date Manufacturer Received: 11/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: DRAGER VENTILATOR; DRAGER VENTILATOR; F&P RT380 ADULT EVAQUA2 BREATHING CIRCUIT; F&P RT380 ADULT EVAQUA2 BREATHING CIRCUIT
• Patient Age: 63 YR