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

Model Number RT210

Device Problem Disconnection (1171)

Patient Problems Cardiac Arrest (1762); Low Oxygen Saturation (2477)

Event Date 07/29/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Method: the complaint device rt210 adult dual-heated 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 while the patient was being turned for care (i.E.To prevent pressure sores and improve blood circulation), that the inspiratory limb of a rt210 adult dual-heated breathing circuit disconnected from the mr290v vented autofeed humidification chamber.It was reported that the respiratory nurse preemptively silenced the medtronic 980 ventilator alarm prior to turning the patient.The circuit disconnected for a period of 13 minutes with visual alarms and notifications active and the nurse did not recognise the alarms.The patient's oxygen saturation level (spo2) continued to drop.The patient subsequently suffered a cardiac arrest.After the incident of cardiac arrest, the patient had a return of spontaneous circulation, increased positive-end expiratory pressure (peep) and oxygen flow rate (fio2) and was subsequently returned to the ventilator.The hospital also reported that it is more than likely that the rt210 adult dual-heated breathing circuit may have been set-up under tension and it is possible that external force may have been exerted on the tubing while the patient was being turned for care.Furthermore, there was no reported damage or malfunction with the rt210 adult dual-heated breathing circuit.The patient has since deceased.However, there is no indication from the healthcare facility of any causal relationship between the patient death and the reported event.Conclusion: we are unable to determine the cause of the reported patient incident.However, based on the information provided by the customer, it is likely that the disconnection of the rt210 inspiratory limb was due to the external force when turning the patient for care.In addition, the audible alarms of the ventilator were silenced, and the visual alarms were not attended to while the tubing was disconnected for 13 minutes.All rt210 adult dual-heated breathing circuits are visually inspected and pressure tested before leaving the production line, and those that fail are rejected.The user instructions that accompany the rt210 adult dual-heated 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." "ensure appropriate ventilator or flow source alarms are set before connecting breathing set to a 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." "do not stretch or milk the tubing.".

Event Description

A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that while the patient was being turned for care (i.E.To prevent pressure sores and improve blood circulation), the inspiratory limb of a rt210 adult dual-heated breathing circuit disconnected from the mr290v vented autofeed humidification.It was reported that the respiratory nurse preemptively silenced the medtronic 980 ventilator alarm prior to turning the patient.The circuit disconnected for a period of 13 minutes with visual alarms and notifications active and the nurse did not recognise the alarms.The patient's oxygen saturation level (spo2) continued to drop.The patient subsequently suffered a cardiac arrest.The patient has since deceased, however there is no indication from the healthcare facility of any causal relationship between the patient death and the reported event.

• Brand Name: ADULT DUAL HEATED BREATHING CIRCUIT
• Type of Device: BTT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 10723386
• MDR Text Key: 212697710
• Report Number: 9611451-2020-00907
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: K983112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RT210
• Device Catalogue Number: RT210
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/23/2020
• Initial Date FDA Received: 10/22/2020
• 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
• Treatment: F&P MR290V AUTOFEED HUMIDIFICATION CHAMBER; F&P MR850 HUMIDIFIER; MEDTRONIC 980 VENTILATOR
• Patient Outcome(s): Other