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

Model Number OPT970

Device Problems Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)

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

Event Date 12/28/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4) fisher & paykel healthcare (f&p) is currently in the process of completing our investigation.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 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.

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 damage as a result of being pulled by the patient during use.There were no patient consequences.

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 detached from the three-way connector as a result of being pulled by the patient during use.There were no patient consequences.

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 not returned to f&p for evaluation.The healthcare facility stated that the subject device was discarded.Our investigation is based on the information and photograph 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 detached from the three-way connector.The healthcare facility reported that the tubing was broken due to the patient pulling the subject device.There were no patient consequences reported by the healthcare facility.Conclusion: our investigation was unable to determine the exact cause of the observed damage to the opt970 optiflow + tracheostomy direct connection.However, the healthcare facility reported that the tubing was broken due to the patient pulling the subject device.Based on our knowledge of the product and the information provided by the healthcare facility the tubing was likely subjected to excessive force.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.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: "do not crush or stretch tube, to prevent loss of therapy." "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." "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.".

• 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: 18620096
• MDR Text Key: 334882783
• Report Number: 9611451-2024-00062
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012436917
• UDI-Public: (01)09420012436917(10)2102375549(11)221006
• 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: 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• 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: 2102375549
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/06/2022
• 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