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

Model Number RT266

Device Problem Moisture or Humidity Problem (2986)

Patient Problem Low Oxygen Saturation (2477)

Event Type  Injury  

Manufacturer Narrative

(b)(4).No devices were returned to fisher & paykel healthcare (fph) in (b)(6) for inspection.This complaint was not about a malfunction of any particular device.Although the incidents reported by the mother of the patient allegedly took place in (b)(6) 2016, fph was not informed of these events until september 2017, when we received an email from the mother of the infant.At that time we were not informed what devices had been involved or at which hospital the incidents had occurred.Fph made numerous attempts to obtain further information from the the parents of the infant and we were finally able to ascertain on 22 november 2017 what devices had been used and which hospital was involved.Based on the information we have received, the infant was on a respiratory system that included an rt266 infant breathing circuit and a ram cannula.The ram cannula is not designed to be used with the rt266 circuit and this combination could cause excess condensate in the breathing circuit.Fph contacted the hospital for comment about the alleged incidents.The hospital confirmed that they had experienced condensation issues when using the rt266 in conjunction with the ram cannula.However they stated that they could not confirm any incidents related to (b)(6) infant.Our user instructions that accompany the rt266 infant dual heated evaqua2 breathing circuit state the following: attention: - set appropriate ventilator alarms.- check breathing circuits for condensation every 6 hours and drain if required.Warning: - when mounting a humidifier adjacent to a patient ensure that the humidifier is always positioned lower than the patient.- the use of circuit/chamber combinations not recommended by fisher & paykel healthcare may result in poor humidification system performance, ventilator malfunction, and harm to the patient/user.The rt266 circuit is used in conjunction with the fph mr850 humidifier.The mr850 user instructions contain the following warning: - the use of breathing circuits, chambers or other accessories which are not approved by fisher & paykel healthcare may impair performance or compromise safety.During a site visit at the hospital in august 2016, fph representatives were informed that the hospital was having issues with condensation and had advised the hospital to rather use our optiflow junior cannula with the rt266 breathing circuit.

Event Description

A mother reported that while her infant was being treated at a hospital in (b)(6) , the nurse moved the infant to check for condensation in the rt266 infant dual-heated evaqua2 breathing circuit.The mother further alleged that condensate then entered the nares of the infant and that the infant "flat-lined".The mother stated that staff then administered chest compressions and bagging and the infant recovered.The mother reported that this occurred in (b)(6) 2016, on two separate occasions.The infant was approximately (b)(6) premature, born at (b)(6) gestation.

• 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: sharon kuruvilla ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 7132766
• MDR Text Key: 95325773
• Report Number: 9611451-2017-01226
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial
• Report Date: 11/22/2017

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: RT266
• Device Catalogue Number: RT266
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/22/2017
• Initial Date FDA Received: 12/19/2017
• 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: RAM CANNULA
• Patient Outcome(s): Required Intervention
• Patient Age: 27 WK