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 02/18/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Fisher & paykel healthcare (f&p) is currently in the process of retrieving the subject device for evaluation.We will provide a follow up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported that the tubing of an opt944 optiflow + adult nasal cannula was found damaged during patient use.It was reported that the patient desaturated to 92% spo2 for three minutes.The subject cannula was replaced.No further patient consequences were reported.

Event Description

A healthcare facility in france reported that the tubing of an opt944 optiflow + adult nasal cannula was found damaged during patient use.It was reported that the damage occurred during a medical procedure involving the placement of central femoral catheters.It was further reported that the patient desaturated to 92% spo2.The subject cannula was replaced and fio2 was increased and the patient recovered after three minutes.No further patient consequences were reported.

Manufacturer Narrative

(b)(6).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 healthcare facility provided further information upon request, and the complaint opt944 optiflow + adult nasal cannula was returned to fisher & paykel healthcare in new zealand for investigation, where it was visually inspected.Our investigation is thus based on the information provided by the healthcare facility, the evaluation of the complaint cannula and our knowledge of the product.Results: the healthcare facility reported that the reported damage occurred during a medical procedure involving the placement of central femoral catheters.Visual inspection of the returned cannula revealed that the left hook and hook sleeve were detached from the nasal prong.The tubing was also found to be damaged near the head strap clip.Conclusion: we are unable to determine the cause of the reported damage to the subject opt944 optiflow + adult nasal cannula.However, based on the information reported by the healthcare facility our knowledge of the product, the reported event was likely caused by the cannula being subjected to excessive force during use.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.".

• 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: 13657271
• MDR Text Key: 289199597
• Report Number: 9611451-2022-00204
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012429117
• UDI-Public: (01)09420012429117(10)2101604200(11)210420
• 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,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2022
• 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
• Device Lot Number: 2101604200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2021
• 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: 74 YR