MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD OPTIFLOW JUNIOR INTERFACE; BTT

Model Number OPT318

Device Problem Crack (1135)

Patient Problem Low Oxygen Saturation (2477)

Event Type  malfunction  

Event Description

A healthcare facility in california reported, via a fisher and paykel healthcare (f&p) field representative, that an opt318 optiflow junior nasal cannula was found cracked, excessive condensation and water was coming out of the canula during patient's use.The healthcare facility also reported that the patient felt as couldn't breathe and the oxygen saturation decreased to 90%.Once the subject cannula has been removed and replaced with another cannula, the problem solved, and no additional treatment was needed.No further patient's consequences were reported.

Manufacturer Narrative

(b)(4).Fisher and paykel (f&p) are currently in the process of obtaining further information regarding the reported event.We have also requested the return of the subject opt318 optiflow junior nasal cannula to f&p new zealand for investigation.We will provide a follow up report upon completion of our investigation.

Manufacturer Narrative

(b)(4).Corrected data: (f&p) field representative provided a correct model number.Therefore, the model number amended from opt318 optiflow junior nasal cannula to ojr418 optiflow junior 2 nasal cannula in sections b.5 and d.4.Accordingly, d.1 and d.2 were changed.Method: the complaint ojr418 optiflow junior 2 nasal cannula was received at fisher & paykel healthcare (f&p) in new zealand for evaluation where it was visually inspected.Results: visual inspection of the complaint cannula confirmed that there were no cracks and tears observed in the ojr418 optiflow junior 2 nasal cannula.Conclusion: we are unable to determine the cause of the reported event.However, it is most likely due to the use of a saline solution that cause a corrosion of stainless-steel wire.The user instructions illustrate in pictorial format the correct set-up and proper use of the optiflow junior 2 nasal cannula.They also state the following: appropriate patient monitoring (e.G.Oxygen saturation) must be used at all times.Failure to monitor the patient (e.G.In the event of an interruption to gas flow) may result in serious harm or death.Do not wrap, insulate, stretch or crush the tubing as this may impair the performance of this product or compromise safety(including potentially causing patient harm).Ensure all connections are secure during use.Check the cannula is undamaged and that the flow path is maintained.Under excessive load, the cannula may disconnect to prevent forces being transferred to the patient.All optiflow junior cannulas are 100% leak and occlusion tested after final assembly and any cannula that fails is discarded.Samples are also taken and pull tested to check the tube tensile strength and the glue joint strength at the cannula/tube joint, as well as the swivel grip joint.The subject cannula would have met the required specification at time of production.

Event Description

A healthcare facility in california reported, via a fisher and paykel healthcare (f&p) field representative, that an ojr418 optiflow junior 2 nasal cannula was found cracked, excessive condensation and water was coming out of the canula during patient's use.The healthcare facility also reported that the patient felt as couldn't breathe and the oxygen saturation decreased to 90%.Once the subject cannula has been removed and replaced with another cannula, the problem solved, and no additional treatment was needed.No further patient's consequences were reported.

• Brand Name: OPTIFLOW JUNIOR INTERFACE
• 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: omid taheri ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 8007923912
• MDR Report Key: 17741262
• MDR Text Key: 323408562
• Report Number: 9611451-2023-00855
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/15/2023
• 2 Devices were Involved in the Event: 1 2

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: OPT318
• Device Catalogue Number: OPT318
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2023
• Initial Date FDA Received: 09/13/2023
• Supplement Dates Manufacturer Received: 11/12/2023
• Supplement Dates FDA Received: 12/11/2023
• 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