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

Model Number RT380

Device Problem Disconnection (1171)

Patient Problems Bradycardia (1751); Low Oxygen Saturation (2477)

Event Date 05/06/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Method: the complaint rt380 adult dual heated evaqua2 breathing circuit was not returned to fisher & paykel healthcare for evaluation.Our investigation is based on the information provided by the customer and our knowledge of the product.Results: the customer reported that on (b)(6) 2021 the inspiratory limb of an rt380 adult dual heated evaqua2 breathing circuit disconnected at the y-piece during patient use.It was also reported that the patient desaturated and experienced bradycardia at 30 bpm.The hospital further reported that the disconnection could have been due to patient coughing effort and the circuit system was reconnected following the observation by the nurse.The patient saturation levels improved and the subject rt380 remained in use for another three days following the incident.On (b)(6) 2021 the patient was transferred out of intensive care to a conventional hospital ward.No further patient consequences were reported.Conclusion: without the return of the complaint device, we were unable to determine the cause of the reported event.It was also reported that the nurse re-connected the inspiratory limb of the subject rt380 circuit and the device was in use for an additional three days without any issues.It was also noted that the rt380 adult dual heated evaqua2 breathing circuit passed the initial leak test at the healthcare facility prior to use on the patient.All rt380 adult evaqua2 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.The user instructions that accompany the rt380 breathing circuit state the following: check all connections are tight before use.Ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient 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 (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that on (b)(6) 2021 the inspiratory limb of an rt380 adult dual heated evaqua2 breathing circuit disconnected at the y-piece during patient use.It was also reported that the patient desaturated and experienced bradycardia at 30 bpm.The hospital further reported that the disconnection could have been due to patient coughing effort and the circuit system was reconnected following the observation by the nurse.The patient saturation levels improved and the subject rt380 remained in use for another three days following the incident.On (b)(6) 2021 the patient was transferred out of intensive care to a conventional hospital ward.No further patient consequences were reported.

• Brand Name: ADULT 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
• MDR Report Key: 11936615
• MDR Text Key: 254461010
• Report Number: 9611451-2021-00636
• Device Sequence Number: 1
• Product Code: BZE
• UDI-Device Identifier: 09420012429728
• UDI-Public: 010942001242972810210150846311210
• Combination Product (y/n): N
• PMA/PMN Number: K103767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT380
• Device Catalogue Number: RT380
• Device Lot Number: 2101508463
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2021
• 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
• Patient Outcome(s): Other