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

Model Number RT268

Device Problems Disconnection (1171); Infusion or Flow Problem (2964)

Patient Problem Low Oxygen Saturation (2477)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Fisher & paykel healthcare are currently in the process of retrieving further information regarding this complaint.We have requested the return of the complaint devices.We will provide a follow up report upon the completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that the pressure line of an rt268 infant evaqua2 breathing circuit disconnected while in use on a patient.The breathing circuit was connected to the ventilator and approximately four hours later it was noted that the patient's oxygen saturations had dropped from the high 90s to the high 70s.In response to this, the clinician checked the set-up and noted that there was no pressure being delivered to the patient they do not recall any ventilator alarms sounding at this time.The patient was manually ventilated and then moved to a different ventilator.The healthcare facility also reported that two other rt268 infant evaqua2 breathing circuits were observed to have loose pressure lines prior to patient use.It was reported that the patient deceased a few hours later.The healthcare facility noted the patient had complex underlying medical conditions and advised that they did consider that the death was directly related to the reported event.

Event Description

A healthcare facility in the united kingdom reported via a fisher & paykel healthcare (f&p) field representative that the pressure line of an rt268 infant evaqua2 breathing circuit disconnected while in use on a patient.The breathing circuit was connected to the ventilator and approximately four hours later it was noted that the patient's oxygen saturations had dropped from the high 90s to the high 70s.In response to this, the clinician checked the set-up and noted that there was no pressure being delivered to the patient.They do not recall any ventilator alarms sounding at this time.The patient was manually ventilated and then moved to a different ventilator.The healthcare facility also reported that two other rt268 infant evaqua2 breathing circuits were observed to have loose pressure lines prior to patient use.The healthcare facility noted that the patient had complex underlying medical conditions and passed away a few hours later.They did not consider that the death was directly related to the reported event.

Manufacturer Narrative

(b)(4).Corrections: b5: the hospital statements were incorrectly transcribed and corrected as ".Noting that they did not consider that the death was directly related to the reported event".Method: the rt268 infant evaqua2 breathing circuit was not returned to fisher & paykel healthcare (f&p) new zealand for evaluation as it was discarded by the customer following the reported event.However, two unused rt268 infant evaqua2 breathing circuits from the same lot were returned for investigation.In addition, the healthcare facility provided further information upon request.Our investigation was based on the information and photographs provided by the healthcare facility, the evaluation of the returned rt268 infant evaqua2 breathing circuits and the knowledge of the product.Results: visual inspection of the returned breathing circuits did not identify any defects or damage.Measurements confirmed the products were within specification.Functional testing confirmed a secure connection could be made when the pressure line was fully inserted into the connection port.In addition, dimensional testing was performed on retained samples from the same lot of the pressure line port and elbow components and confirmed to be within specification.Conclusion: we were unable to replicate the customer's experience as our investigation confirmed that the returned devices were within specification.The healthcare facility noted that the pressure line was disconnected from the pressure line elbow.Based on our knowledge of the product, it is possible that the pressure line may not have been fully inserted at the time of set up, therefore increasing the risk of an inadvertent disconnection.The healthcare facility reported that the patient had complex medical needs and the reported disconnection was unrelated to the patient's death.Fisher & paykel healthcare's (f&p) internal records indicate that the healthcare facility has not purchased the rt268 infant evaqua2 breathing circuit within the last five years.User instructions that accompany the rt268 shows the correct connection of the pressure line and includes the following warnings: · 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.Failure to comply with any of the following warnings may impair performance of the device or compromise safety (including potentially causing serious harm): · visually inspect breathing sets for damage (e.G.A crushed tube or cracked connector) before use, and replace if damaged.Attention: · ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient.· check all connections are tight before use.

• 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 ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494534000
• MDR Report Key: 13925298
• MDR Text Key: 288010370
• Report Number: 9611451-2022-00229
• Device Sequence Number: 1
• Product Code: BZE
• UDI-Device Identifier: 09420012431158
• UDI-Public: (01)09420012431158(10)2101357863(11)201105
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K103767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT268
• Device Catalogue Number: RT268
• Device Lot Number: 2101357863
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2020
• 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 MR850 RESPIRATORY HUMIDIFIER.; F&P MR850 RESPIRATORY HUMIDIFIER.; SLE5000 VENTILATOR.; SLE5000 VENTILATOR.
• Patient Outcome(s): Other
• Patient Age: 28 DA