MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD BI-LEVEL/CPAP INSPIRATORY HEATED CIRCUIT; BTT

Model Number RT219

Device Problem Moisture or Humidity Problem (2986)

Patient Problems Stroke/CVA (1770); Pneumonia (2011); Obstruction/Occlusion (2422); Respiratory Failure (2484)

Event Date 03/22/2021

Event Type  Death  

Manufacturer Narrative

(b)(4).Method: the complaint rt219 adult bi-level/cpap breathing circuit was requested; however, it was not returned to f&p for evaluation as the circuit was disposed of by the healthcare facility.Our investigation is thus based on the information provided by the hospital, expert clinical advice and our knowledge of the product.Results:a healthcare facility reported on behalf of a patient's wife, via a fisher & paykel healthcare (f&p) field representative, that a patient receiving end-of-life care deceased on (b)(6) 2021 whilst using the rt219 adult bi-level/cpap breathing circuit as part of non-invasive ventilation (niv) therapy.The healthcare facility reported that the patient presented with several pre-existing health conditions, including coronary artery disease, history of tongue cancer, history of gastrointestinal bleeding, severe dysphagia and graves' disease.The patient was admitted to hospital on (b)(6) 2021 due to acute stroke.During their hospital stay, the patient's respiratory status declined and was receiving medication to relieve breathlessness for end-of-life care.The patient was placed on the rt219 adult bi-level/cpap breathing circuit from (b)(6) 2021 until they deceased.The healthcare facility further reported the medical cause of death was due to acute ischemic stroke, progressive respiratory failure due to pneumonia and severe dysphagia.The patient's wife believes that the rt219 breathing circuit had condensation which caused the patient's aspiration pneumonia and his death; however, the hospital's respiratory therapy manager stated that "the amount of condensation in the rt219 breathing circuit was not anything out of the ordinary".Conclusion: the healthcare facility reported that the patient was receiving end-of-life care when placed on the rt219 adult bi-level/cpap breathing circuit.It was further reported that the medical cause of death was due to acute ischemic stroke, progressive respiratory failure due to pneumonia and severe dysphagia.The hospital's respiratory therapy manager also reported that "the amount of condensation in the rt219 breathing circuit was not anything out of the ordinary".In addition, hospital staff verified the bipap system at the time to ensure heat was appropriately applied to humidify the patient's airways and noted that no alarms were activated from the equipment.Condensation in the humidification system, although ideally minimized, is an expected consequence of heated pass-over humidification systems in many conditions and may vary between light misting to water droplets that form on the wall of cool breathing circuit tubing.The amount of condensate in the ventilation system is influenced by a number of multiple setup and environmental factors.A review of the reported incident from a clinical expert confirmed that condensation in the rt219 circuit "is not associated with the transmission of microorganisms from the humidification chamber to the circuit".The clinical expert further described that the patient's pneumonia was likely as a result of abnormal colonisation of organisms in the mouth in addition to the patient's pre-existing conditions, including tongue cancer, dysphagia and acute stroke; which impair the effectiveness of coughing, increasing the risk of aspiration.Based on this information, there are no indications of any fault with the rt219 circuit and no indication that the product caused or contributed to the event.The user instructions that accompany the rt219 bi-level/cpap breathing circuit include a pictorial showing the instructions to connect the circuit and exhalation port correctly.It also includes 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.Ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient.Regularly monitor and drain condensate build-up in the circuit.Check all connections are tight before use.

Event Description

A healthcare facility reported on behalf of a patient's wife, via a fisher & paykel healthcare (f&p) field representative, that a patient receiving end-of-life care deceased on (b)(6) 2021 whilst using the rt219 adult bi-level/cpap breathing circuit as part of non-invasive ventilation (niv) therapy.The patient was admitted to hospital on (b)(6) 2021 due to acute stroke.During their hospital stay, the patient's respiratory status declined and was receiving medication to relieve breathlessness for end-of-life care.The patient was placed on the rt219 adult bi-level/cpap breathing circuit from (b)(6) 2021 until they deceased.The healthcare facility further reported the medical cause of death was due to acute ischemic stroke, progressive respiratory failure due to pneumonia and severe dysphagia.The patient's wife believes that the rt219 breathing circuit had condensation which caused the patient's aspiration pneumonia and his death; however, the hospital's respiratory therapy manager stated that "the amount of condensation in the rt219 breathing circuit was not anything out of the ordinary".

• Brand Name: BI-LEVEL/CPAP INSPIRATORY HEATED 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 ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 11712683
• MDR Text Key: 246951832
• Report Number: 9611451-2021-00408
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012401311
• UDI-Public: (01)09420012401311(10)2100716796(11)190305
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RT219
• Device Catalogue Number: RT219
• Device Lot Number: 2100716796
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2019
• 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: NON F&P MASK; PHILIPS V60 VENTILATOR
• Patient Outcome(s): Death