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

Model Number OPT944

Device Problems Break (1069); Material Split, Cut or Torn (4008)

Patient Problem Low Oxygen Saturation (2477)

Event Date 07/07/2022

Event Type  malfunction  

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 under a patient's shoulder while they were lying on their side.When the patient was turned over by the medical staff the tubing was found damaged.The patient desaturated from 93% spo2 to 78% spo2.It was also reported that the patient was placed on a mask at high concentration while the cannula was replaced.The healthcare facility reported that the patient had covid-19 and multiple sclerosis.It was also reported that the patient had do not intubate orders and was placed on the therapy for comfort as they had limited treatment options.The healthcare facility further reported that the patient deceased one day after the reported event for reasons unrelated to the reported event.

Manufacturer Narrative

(b)(4).As the patient had covid-19, the healthcare facility has discarded the subject opt944 optiflow + adult nasal cannula and so it cannot be returned to fisher & paykel healthcare (f&p) for evaluation.F&p is currently in the process of retrieving further information, including the sequence of events and the medical cause of death.We will provide a follow up report upon completion of our investigation.Product background: the opt944 optiflow + adult nasal cannula is a nasal cannula patient interface for delivery of humidified respiratory gases.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.

Manufacturer Narrative

(b)(4).Product background: the opt944 optiflow + adult nasal cannula is a nasal cannula patient interface for delivery of humidified respiratory gases.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: as the patient had covid-19, the healthcare facility discarded the subject opt944 optiflow + adult nasal cannula and so was not returned to fisher & paykel healthcare (f&p) for evaluation.Several attempts to request further information from the healthcare facility were also made, however no response was provided by the healthcare facility.Our investigation is based on the initial information provided by the customer, and our knowledge of the product.Results: the healthcare facility reported that the tubing of the opt944 optiflow + adult nasal cannula was found under a patient's shoulder while they were lying on their side.When the patient was turned over by the medical staff the tubing was found damaged.The healthcare facility also reported that the tubing clip was not used.Conclusion: our investigation was unable to determine the cause of the observed damage to the subject opt944 optiflow + adult nasal cannula.Based on our knowledge of the product, the reported damage is likely to have been caused by the tubing being subjected to excessive force when laid on by the patient and during movement of the patient by the medical staff.Manufacturing controls include inspections during production for visual defects to the optiflow + tubing and the swivel, including cracks, tears, moulding defects, contamination, inclusions, discoloration and stretching or deformation.The optiflow + tubing is also inspected for any assembly defects, including confirmation the swivel and 3-way connector are connected with the correct engagement.Any product that fails the visual inspection is disposed of.The subject opt944 optiflow + adult nasal cannula would 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 head strap 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 france reported via a fisher & paykel healthcare (f&p) field representative that the tubing of an opt944 optiflow + adult nasal cannula was found under a patient's shoulder while they were lying on their side.When the patient was turned over by the medical staff the tubing was found damaged.The patient desaturated from 93% spo2 to 78% spo2.It was also reported that the patient was placed on a mask at high concentration while the cannula was replaced.The healthcare facility reported that the patient had covid-19 and multiple sclerosis.It was also reported that the patient had do not intubate orders and was placed on the therapy for comfort as they had limited treatment options.The healthcare facility further reported that the patient deceased one day after the reported event for reasons unrelated to the reported event.

• 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 ; 9494534002
• MDR Report Key: 15237687
• MDR Text Key: 298040928
• Report Number: 9611451-2022-00721
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2022
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 58 YR
• Patient Sex: Female