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 01/10/2022

Event Type  Death  

Manufacturer Narrative

(b)(4).Fisher & paykel healthcare (f&p) is currently in the process of retrieving further information regarding the reported event.We will provide a follow up report upon completion of our investigation.

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 damaged during use on a covid-19 patient.The patient desaturated and the subject cannula was removed and replaced with another opt944 nasal cannula.It was reported that the patient deceased approximately 5 minutes later.The healthcare facility noted that the patient was at the end of life.Further information has been requested regarding the reported event and the medical cause of death.

Manufacturer Narrative

(b)(4).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).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.Several attempts to request further information from healthcare facility were also made, however no response was provided by the healthcare facility.Results: visual inspection of the returned cannula revealed that the tubing was stretched and torn.Further information about the reported incident and the medical cause of death was requested but was not provided.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 stretched and torn, the reported event was likely caused by the cannula being subjected to excessive force.It should be noted that the patient was covid-19 positive and was at the end of life.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.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 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 france reported via a fisher & paykel healthcare (f&p) field representative that the tubing of an opt944 optiflow + adult nasal cannula was found damaged during use on a covid-19 patient.The patient desaturated and the subject cannula was removed and replaced with another opt944 nasal cannula.It was reported that the patient deceased approximately 5 minutes later.The healthcare facility noted that the patient was at the end of life.Further information about the reported incident and the medical cause of death was requested from the healthcare facility.However, the healthcare facility did not provide any of the requested information despite several attempts to request this.

• 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 ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534002
• MDR Report Key: 13502520
• MDR Text Key: 285387396
• Report Number: 9611451-2022-00134
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012429117
• UDI-Public: (01)09420012429117(10)2101417545(11)201202
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OPT944
• Device Catalogue Number: OPT944
• Device Lot Number: 2101417545
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2022
• Initial Date FDA Received: 02/09/2022
• Supplement Dates Manufacturer Received: 03/20/2022
• Supplement Dates FDA Received: 04/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2020
• 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
• Patient Outcome(s): Death
• Patient Age: 58 YR