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

Model Number OPT944

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Low Oxygen Saturation (2477)

Event Date 10/30/2021

Event Type  malfunction  

Event Description

A healthcare facility in (b)(6) reported, via a fisher & paykel healthcare (f&p) field representative, that a patient desaturated to 71% spo2 when the tubing of an opt944 optiflow + adult nasal cannula was found detached from the 3-way connector after three days of use.Staff described that the patient was found to be cyanotic, dyspnoeic, and panicked.Staff immediately replaced the cannula and increased the fio2 to 95%.Within five minutes, spo2 levels increased to 86%.Further information was requested and it was disclosed that the patient had deceased.The hospital stated that the medical cause of death was cancer.

Manufacturer Narrative

(b)(4).The complaint opt944 optiflow + adult nasal cannula is currently en route to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow up report upon completion of investigation.

Manufacturer Narrative

(b)(4).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 cannula was received at fisher & paykel healthcare (f&p) in new zealand for investigation where it was visually inspected.Results: visual inspection of the complaint opt944 optiflow + adult nasal cannula revealed that the tubing was detached from the 3-way connector.The tubing was found stretched at the manifold and at the connector end.Conclusion: we are unable to determine what caused the reported fault.However, from the findings of the visual inspection, it is likely caused by the tubing being pulled.The hospital stated that following the reported fault, the patient had increased to 86% spo2.The patient deceased three days later, the medical cause of death was cancer and was unrelated to the reported fault.Optiflow interfaces undergo tensile testing and are inspected during production for visual defects including cracks, tears, inclusions, discoloration and stretching or deformation.Any product that undergoes destructive testing or fails the visual inspection is disposed of.The user instructions which accompany the opt944 optiflow + adult nasal cannula show in pictorial format the correct placement and fitting of the cannula and states: - "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." - "attach tubing clip to clothing/bedding to prevent cannula from pulling off face." - "failure to use the set-up described above can compromise performance and affect patient safety.".

Event Description

A healthcare facility in france reported, via a fisher & paykel healthcare (f&p) field representative, that on (b)(6) 2021, a patient desaturated to 71% spo2 when the tubing of an opt944 optiflow + adult nasal cannula was found detached from the 3-way connector after three days of use.Staff described that the patient was found to be cyanotic, dyspnoeic, and panicked.Staff immediately replaced the cannula and increased the fio2 to 95%.After five minutes, the spo2 levels increased to 86%.Further information was requested and it was disclosed that the patient had deceased on (b)(6) 2021.The hospital stated that the medical cause of death was cancer.

• 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: 13058331
• MDR Text Key: 286341075
• Report Number: 9611451-2021-01352
• 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,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 11/25/2021

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: OPT944
• Device Catalogue Number: OPT944
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/25/2021
• Initial Date FDA Received: 12/22/2021
• Supplement Dates Manufacturer Received: 01/20/2022
• Supplement Dates FDA Received: 02/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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 900PT561 HEATED BREATHING TUBE AND CHAMBER KIT.; F&P 900PT561 HEATED BREATHING TUBE AND CHAMBER KIT.; F&P PT101 AIRVO 2 HUMIDIFIER.; F&P PT101 AIRVO 2 HUMIDIFIER.
• Patient Sex: Female