MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD INFANT CONTINUOUS FLOW BREATHING CIRCUIT; BTT

Model Number RT124

Device Problems Break (1069); Gas/Air Leak (2946)

Patient Problems Hypoxia (1918); Discomfort (2330)

Event Date 10/18/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The rt124 breathing circuit is not sold in the usa but is similar to a product which is sold in the usa.The 510(k) number of the similar product is k020332.The customer is returning a number of rt124 infant continuous flow single heated breathing circuits.These are currently en route to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow-up report upon completion of our investigation.

Event Description

A healthcare facility in lille reported that a rt124 infant continuous flow single heated breathing circuit was found to be leaking air during patient use due to a crack in the inspiratory tube.It was unclear from the reported information what the outcome was for the patient as the information indicates that the patient experienced discomfort or faintness.We have requested further clarification on the reported patient consequences.

Manufacturer Narrative

(b)(4).Method: f&p healthcare requested for the return of the subject rt124 infant continuous flow single heated breathing circuit for investigation.On receipt of the product, it was identified that the subject device was not manufactured or distributed by f&p healthcare.Inspection of the returned product identified a defect that may have resulted in the leakage reported by the healthcare facility.Further information on the reported patient consequences was requested, however no further information was provided.Results: the customer reported that a rt124 infant continuous flow single heated breathing circuit was found to be leaking air during patient use due to a crack in the inspiratory tube.However inspection of the returned device confirmed that this product was not manufactured by f&p healthcare.Conclusion: review of the returned device confirmed that it was not manufactured or distributed by f&p healthcare.The product will be returned to the healthcare facility for identification and notification of the correct manufacturer.All rt124 infant continuous flow single heated breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The subject breathing circuit would have met the required specifications at the time of production.Our user instructions that accompany the rt124 infant continuous flow single heated breathing circuit state the following: - "do not soak, wash, sterilize, or reuse this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers." "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient." "ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient.".

Event Description

A healthcare facility in france reported that a rt124 infant continuous flow single heated breathing circuit was found to be leaking air during patient use due to a crack in the inspiratory tube.It was unclear from the reported information what the outcome was for the patient as the information indicates that the patient experienced discomfort or faintness.We have requested further clarification on the reported patient consequences.

• Brand Name: INFANT CONTINUOUS FLOW BREATHING CIRCUIT
• 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: 16040516
• MDR Text Key: 306086442
• Report Number: 9611451-2022-01197
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: SEE H10
• 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: 11/23/2022

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: RT124
• Device Catalogue Number: RT124
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/23/2022
• Initial Date FDA Received: 12/22/2022
• Supplement Dates Manufacturer Received: 01/25/2023
• Supplement Dates FDA Received: 02/01/2023
• 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