MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT; BZE

Model Number RT266

Device Problems Decrease in Pressure (1490); Detachment of Device or Device Component (2907)

Patient Problem Irritability (2421)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are in the process of completing our investigation.We will provide a follow up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(4) reported via a fisher & paykel healthcare (f&p) field representative, that the port cap of a rt266 infant dual-heated evaqua2 breathing circuit came off during use on an intubated patient.The port cap was replaced by a non f&p "red cap" which also came off resulting in loss of ventilation pressure and patient agitation.It was also reported that the patient was extubated and then re-intubated.The patient remains intubated.No further patient consequences were reported.

Manufacturer Narrative

(b)(4).Method: the complaint rt266 infant dual heated evaqua2 breathing circuit was not returned to fisher & paykel healthcare for investigation.Our investigation is thus based on the information provided by the customer and our knowledge of the product.Results: the customer reported that the port cap of a rt266 infant dual-heated evaqua2 breathing circuit came off during use on an intubated patient.The port cap was replaced by a non f&p "red cap" which also came off resulting in loss of ventilation pressure and patient agitation.It was also reported that the patient was extubated and then re-intubated.Conclusion: without the return of the complaint device, we are unable to determine the cause of the reported event.All rt266 infant dual heated evaqua2 breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The subject infant breathing circuit would have met the required specifications at the time of production.Our user instructions that accompany the rt266 infant dual heated evaqua2 breathing circuit state the following: "check all connections are tight before use." "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient." "set appropriate ventilator alarms.' "visually inspect breathing sets for damage (e.G.A crushed tube or cracked connector) before use and replace if damaged." "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.".

Event Description

A healthcare facility in washington dc reported via a fisher & paykel healthcare (f&p) field representative, that the port cap of a rt266 infant dual-heated evaqua2 breathing circuit came off during use on an intubated patient.The port cap was replaced by a non f&p "red cap" which also came off resulting in loss of ventilation pressure and patient agitation.It was also reported that the patient was extubated and then re-intubated.No further patient consequences were reported.

• Brand Name: INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
• Type of Device: BZE
• 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: 12595444
• MDR Text Key: 276915124
• Report Number: 9611451-2021-01137
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT266
• Device Catalogue Number: RT266
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2021
• 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