MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD OPTIFLOW + ADULT NASAL CANNULA; BTT

Model Number OPT944

Device Problems Stretched (1601); Material Split, Cut or Torn (4008)

Patient Problem Low Oxygen Saturation (2477)

Event Type  malfunction  

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 had torn whilst on a covid-19 positive patient in the intensive care unit (icu).It was further reported that the patient desaturated to 87% for approximately five minutes and the opt944 device was replaced.No further patient consequences were reported.

Manufacturer Narrative

(b)(4).Fisher & paykel healthcare (f&p) are currently in the process of retrieving further information regarding this complaint.Furthermore, the complaint opt944 optiflow + adult nasal cannula is currently en route to f&p for evaluation.We will provide a follow up report upon the completion of our investigation.

Manufacturer Narrative

(b)(4).Product background: the opt944 optiflow + adult nasal cannula is a nasal cannula patient interface for delivery of humidified respiratory gases, including those who are receiving nasal high flow therapy (nhf).Optiflow + interfaces are designed for use with the airvo 2 series of humidification devices.Nhf therapy and the airvo 2 device are intended for use with spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases.The airvo 2 device should not be used for life support purposes, and appropriate patient monitoring must be used at all times.The cannula consists of a lightweight delivery tube connected to a rigid plastic base and soft nasal prongs (nasal interface).This allows the device to be light weight and durable.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) new zealand for investigation, where it was visually inspected.Results: the customer had stated opt944 optiflow + adult nasal cannula was in use for nine days when it was found torn.The covid-19 patient who was in icu desaturated to 87% spo2 and the cannula was replaced, the patient recovered and there were no further patient consequences.Visual inspection of the returned cannula revealed that the tubing was torn next to the 3-way connector and stretched next to the manifold.Conclusion: we are unable to determine the cause of the reported event.However based on our knowledge of the product and our observation that the tubing was in use for nine days without issue, and was stretched and torn when the incident occurred, the reported event was likely caused by the cannula being subjected to excessive force.Manufacturing controls include inspections during production for visual defects including cracks, tears, inclusions, discoloration and stretching or deformation.Any product that fails the visual inspection is disposed of.The subject opt944 optiflow + adult nasal cannula would therefore have met the required specifications.The user instructions which accompany the opt944 optiflow + adult nasal cannula show in pictorial format the correct placement and fitting of the cannula, including ensuring the headstrap clip and the tubing clip are appropriately attached.The user instructions also warn: "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." "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.".

Event Description

A healthcare facility in ohio reported via a fisher & paykel healthcare (f&p) field representative that the tubing of an opt944 optiflow + adult nasal cannula had torn whilst on a covid-19 positive patient in the intensive care unit (icu).It was further reported that the patient desaturated to 87% for approximately five minutes and the opt944 device was replaced.No further patient consequences were reported.

• Brand Name: OPTIFLOW + ADULT NASAL CANNULA
• 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 ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494534000
• MDR Report Key: 13654261
• MDR Text Key: 289270143
• Report Number: 9611451-2022-00191
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2022
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2022
• 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: F&P PT101 AIRVO 2 HUMIDIFIER.; F&P PT101 AIRVO 2 HUMIDIFIER.