MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD OPTIFLOW + TRACHEOSTOMY DIRECT CONNECTION; TRACHEOSTOMY PATIENT INTERFACE

Model Number OPT970

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/04/2023

Event Type  malfunction  

Event Description

A distributor reported on behalf of a healthcare facility in china that the tubing of an opt970 optiflow + tracheostomy direct connection was found damaged before use.There was no patient involvement as the issue was found whilst the device was not in use on a patient.

Manufacturer Narrative

(b)(4).Fisher & paykel healthcare (f&p) has requested for the complaint device to be returned for evaluation.We will provide a follow up report upon completion of our investigation.Product background: the opt970 optiflow + tracheostomy direct connection is a patient interface used for delivery of humidified respiratory gases directly into the patient's tracheostomy.The interface is held in place by 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 tracheostomy.A tubing clip is also provided to support the weight of the circuit and prevent the tubing from being dislodged.Optiflow + interfaces are designed for use with the airvo 2 series of humidification devices and are also compatible with the f&p mr850 and 950 humidification system devices.The airvo 2 device is intended for use with spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases.The airvo 2 should not be used for life support purposes, and appropriate patient monitoring must be used at all times.

Manufacturer Narrative

(b)(4).Product background: the opt970 optiflow + tracheostomy direct connection is a patient interface used for delivery of humidified respiratory gases directly into the patient's tracheostomy.The interface is held in place by 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 tracheostomy.A tubing clip is also provided to support the weight of the circuit and prevent the tubing from being dislodged.Optiflow + interfaces are designed for use with the airvo series humidifiers and are also compatible with the fisher & paykel healthcare (f&p) mr850 and 950 humidification system devices.Optiflow + interfaces are intended for use with spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases.Optiflow + interfaces are not intended for life support and appropriate patient monitoring must be used at all times.Method: the complaint opt970 optiflow + tracheostomy direct connection was received at f&p in new zealand for investigation, where it was visually inspected.Our investigation is based on our evaluation of the subject device, information provided by the healthcare facility, previous investigations of similar complaints, and our knowledge of the product.Results: visual inspection of the opt970 optiflow + tracheostomy direct connection revealed that the tubing was damaged near the three-way connector.The film of the tubing was wrinkled and torn which indicates the damage was consistent with an external force being applied to the tubing.There was no patient involvement as the issue was found whilst the device was not in use on a patient.Conclusion: our investigation was unable to determine the cause of the observed damage to the opt970 optiflow + tracheostomy direct connection.Based on our knowledge of the product the tubing was likely subjected to excessive force near the three-way connector before patient use.F&p's manufacturing controls for the optiflow + tubing include inspections during production for visual defects including cracks, tears, moulding defects, contamination, inclusions, discoloration and stretching or deformation.The subject opt970 optiflow + tracheostomy direct connection would have met the required specifications.The user instructions which accompany the opt970 optiflow + tracheostomy direct connection show in pictorial format the correct placement and fitting of the connection, including ensuring the lanyard and tubing clip are appropriately attached.The user instructions also state: - "attach breathing tube clip to a secure location (e.G., clothing or bedding) to support the interface." - "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." - "the lanyard is designed to minimize loading and movement of the tracheostomy tube.Secure the lanyard properly to avoid accidental decannulation or airway damage." - "failure to use the set-up described above can compromise performance and affect patient safety.".

Event Description

A distributor reported on behalf of a healthcare facility in china that the tubing of an opt970 optiflow + tracheostomy direct connection was found damaged before use.There was no patient involvement as the issue was found whilst the device was not in use on a patient.

• Brand Name: OPTIFLOW + TRACHEOSTOMY DIRECT CONNECTION
• Type of Device: TRACHEOSTOMY PATIENT INTERFACE
• 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: omid taheri ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 8007923912
• MDR Report Key: 17446402
• MDR Text Key: 320319556
• Report Number: 9611451-2023-00720
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012436917
• UDI-Public: (01)09420012436917(10)2102359911(11)220923
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K162553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OPT970
• Device Catalogue Number: OPT970
• Device Lot Number: 2102359911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2023
• Initial Date FDA Received: 08/02/2023
• Supplement Dates Manufacturer Received: 10/25/2023
• Supplement Dates FDA Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2022
• 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