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

Model Number OPT942

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Low Oxygen Saturation (2477)

Event Date 02/27/2022

Event Type  malfunction  

Event Description

A healthcare facility in (b)(6) reported that the strap of an opt942 optiflow + adult nasal cannula had detached and the patient desaturated to 50% spo2.It was further reported that the patient received bag-valve-mask ventilation whilst the complaint opt942 optiflow + adult nasal cannula was replaced.There were no further reported patient consequences.

Manufacturer Narrative

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

Event Description

A healthcare facility in france reported that the strap of an opt942 optiflow + adult nasal cannula had detached and the patient desaturated to 50% spo2.It was further reported that the patient received bag-valve-mask ventilation whilst the complaint opt942 optiflow + adult nasal cannula was replaced.There were no further reported patient consequences.

Manufacturer Narrative

(b)(4).The opt942 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: the healthcare facility had discarded the complaint opt942 optiflow + adult nasal cannula and so it was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is thus based on the information provided by the customer, and our knowledge of the product.Results: further information regarding the reported event including the device setup, sequence events and the patient's condition was requested from the healthcare facility.However, the healthcare facility only confirmed the use of oxygen therapy and further indicated that the patient was in intensive care and had no injuries after the event.The customer has stated that the strap of an opt942 optiflow + adult nasal cannula had detached.Conclusion: without the return of the complaint cannula, we are unable to determine the cause of the reported event.However, based on our knowledge of the product 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 opt942 optiflow + adult nasal cannula would have met the required specifications.The user instructions which accompany the opt942 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.".

• 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: 14009446
• MDR Text Key: 294390898
• Report Number: 9611451-2022-00338
• 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
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 03/23/2022

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: OPT942
• Device Catalogue Number: OPT942
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/23/2022
• Initial Date FDA Received: 04/05/2022
• Supplement Dates Manufacturer Received: 06/20/2022
• Supplement Dates FDA Received: 07/04/2022
• 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