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

Model Number RT219

Device Problems Misconnection (1399); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Respiratory Distress (2045)

Event Type  Injury  

Manufacturer Narrative

(b)(4).We are currently attempting to obtain further information from the hospital to assist in the investigation.We will provide a follow up report upon completion of investigation.

Event Description

A hospital in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that the rt219 bi-level/cpap breathing circuit as part of a non-invasive ventilation (niv) system was incorrectly set-up.The patient was found with the exhalation port attached directly to a philips respironics mask.The patient was intubated as a result.The patient is now discharged from the hospital.

Event Description

A hospital in florida reported via a fisher & paykel healthcare (f&p) field representative that the rt219 bi-level/cpap breathing circuit as part of a non-invasive ventilation (niv) system was incorrectly set-up.The patient was found with the exhalation port attached directly to a philips respironics mask.When attending to the incorrect set up, the decision was made to change the therapy from niv to invasive ventilation because of the patient's hypercapnia.It was further reported that the patient fully recovered and was discharged from the hospital.

Manufacturer Narrative

(b)(4).Method: the complaint device was requested from the hospital but has not been returned to fisher & paykel healthcare for evaluation.The hospital answered some initial questions from us.We have sought further information regarding the complaint and followed up with the hospital however they have not responded to these requests.Therefore, our investigation is based on the information and photographs provided by the hospital.Results: the hospital reported that the patient had been placed on niv due to respiratory distress, and that the patient was being treated with a philips v60 ventilator, a fisher & paykel healthcare rt219 circuit and mr850 humidifier, and a philips af541 leak 1 mask.It was also reported that the system was initially set up correctly by a respiratory therapist.At some point, the system setup was changed to an incorrect setup, whereby the patient's mask was disconnected from the patient port of the circuit and then connected to the outlet of the exhalation port.We have been informed that the hospital was unsure how the misconnection occurred.This incorrect setup allowed the patient to breathe spontaneously but did not provide niv pressure therapy.We understand that the philips v60 ventilator is designed to alarm in this situation with a "high leak" alarm.The hospital stated that appropriate alarms were in place and that the patient was also monitored with remote pulse oximetry.The hospital was unable to determine the length of time before staff responded.When attending to the incorrect set up, the decision was made to change the therapy from niv to invasive ventilation because of the patient's hypercapnia.It was reported that the patient fully recovered and has been discharged.Conclusion: based on the information provided, it is most likely that a user error occurred resulting in an interruption to niv therapy.The user instructions that accompany the rt219 bi-level/cpap breathing circuit includes a pictorial showing the instructions to connect the circuit and exhalation port properly.It also includes the following attention and warnings: check all connections are tight before use do not block or seal the vent holes on the exhalation port.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.Set appropriate ventilator alarms exhalation port must be used with a non-vented interface on a single limb system.Failure to comply may lead to patient inhaling excess carbon dioxide resulting in hypercapnia.

• 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
• MDR Report Key: 8895855
• MDR Text Key: 154610222
• Report Number: 9611451-2019-00779
• 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,health
• Type of Report: Initial,Followup
• Report Date: 07/16/2019

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: RT219
• Device Catalogue Number: RT219
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/16/2019
• Initial Date FDA Received: 08/15/2019
• Supplement Dates Manufacturer Received: 08/09/2019
• Supplement Dates FDA Received: 09/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: F&P MR850 HUMIDIFIER; F&P MR850 HUMIDIFIER; PHILIPS RESPIRONICS MASK AF541; PHILIPS RESPIRONICS MASK AF541; PHILIPS V60 VENTILATOR; V60 VENTILATOR
• Patient Outcome(s): Required Intervention