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

Model Number OPT944

Device Problems Material Separation (1562); Material Split, Cut or Torn (4008)

Patient Problem Low Oxygen Saturation (2477)

Event Type  malfunction  

Event Description

A healthcare facility in the (b)(6) reported that the tubing of two opt944 optiflow + adult nasal cannulas were found damaged.It was further reported that a patient with covid-19 desaturated in both occasions and in one occurence to 64% spo2.The patient recovered once the cannulas were replaced.There was no further patient consequence.

Manufacturer Narrative

(b)((4).Fisher & paykel healthcare (f&p) is currently in the process of retrieving further information and the subject opt944 optiflow + adult nasal cannulas for evaluation.We will provide a follow up report upon completion of our investigation.

Manufacturer Narrative

Ps(b)(4).Device 1: lot 2101297146, udi (b)(4), date of manufacturing: 09-18-2020 device 2: lot 2101557332, udi(b)(4), date of manufacturing: 03-18-2021 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).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 cannulas were not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the information and photographs provided by the customer.Results: visual inspection of the provided photographs revealed that the tubing of one of the two complaint opt944 optiflow + adult nasal cannulas was stretched and pulled apart at the manifold.Conclusion: we are unable to determine the cause of the reported damages to the subject opt944 optiflow + adult nasal cannulas.However, the damage observed was likely caused by the tubing being pulled.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 rejected.The subject cannulas would have met the specification at the time of production.The user instructions which accompany the opt944 optiflow + adult nasal cannula show in pictorial format the correct placement and fitting of the cannula and also warn: - "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 the netherlands reported that the tubing of two opt944 optiflow + adult nasal cannulas were found damaged.It was further reported that the covid-19 patient desaturated in both instances, in one case to 64% spo2.The patient recovered once the cannulas were replaced.There were no further reported patient consequences.

• 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 ; 9494534000
• MDR Report Key: 12913735
• MDR Text Key: 282961928
• Report Number: 9611451-2021-01349
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012429117
• UDI-Public: (01)09420012429117(10)2101297146(11)200918
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K162553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• 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: SEE H10
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2020
• 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 RT232 ADULT OPTIFLOW CIRCUIT KIT MICROCELL.; F&P RT232 ADULT OPTIFLOW CIRCUIT KIT MICROCELL.; OPT944 OPTIFLOW + CANNULA LOT : 2101557332.; PHILIPS V60 VENTILATOR.; PHILIPS V60 VENTILATOR.
• Patient Age: 62 YR
• Patient Sex: Female