MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD RESPIRATORY HUMIDIFIER; BTT

Model Number MR850

Device Problems Device Alarm System (1012); Temperature Problem (3022); Device Handling Problem (3265)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Type  Injury  

Manufacturer Narrative

(b)(4).We are still attempting to obtain the subject complaint mr850 respiratory humidifier for further investigation.We will provide a follow up report upon completion of our investigation.

Event Description

A hospital in (b)(6) reported via a distributor to a fisher & paykel healthcare (f&p) field representative that a mr850 respiratory humidifier, used with an intersurgical breathing circuit, 900mr869 temperature/flow probe, bc190 flexitrunk infant nasal tubing, bc nasal prongs and a non-f&p gorro cpap were used on an incubated neonate.Clinical staff reported detecting that the patient circuit was allegedly delivering hot air and the mr850 displayed a temperature of 34 °c and did not alarm.It was reported that clinical staff removing the patient interface and protective material from the (b)(6) found a nasal apex necrosis, second degree burn with serious fluid to the nose of the (b)(6).

Event Description

A distributor (técnica electo medica s.A) in colombia reported to fisher & paykel healthcare (f&p) that an f&p mr850 respiratory humidifier, used with an intersurgical breathing circuit, f&p 900mr869 temperature/flow probe, f&p bc190 flexitrunk infant nasal tubing, f&p bc nasal prongs and a non-f&p gorro cpap were used on an incubated neonate.Clinical staff reported detecting that the patient circuit was allegedly delivering hot air and the mr850 displayed a temperature of 34 °c and did not alarm.It was reported that clinical staff removing the patient interface and protective material from the neonate found a nasal apex necrosis, second degree burn with serious fluid to the nose of the neonate.Following the received complaint, an f&p representative got immediately in contact with the distributor to provide training and to show how to correctly use the mr850 humidifier.Training on the user instruction will also be provided emphasising f&p product usage, correct setup and troubleshooting sessions.F&p received confirmation from the distributor that hospital staff (respiratory therapists and biomedical engineers) were trained by the distributor 26 - 27 july 2018.

Manufacturer Narrative

(b)(4).Method: the subject f&p mr850 respiratory humidifier and its accessories (f&p 900mr806 heater wire adaptor for heated breathing circuits, lot date & f&p 900mr869 temperature / flow probe) were returned to fph in new zealand for evaluation.The returned units were performance tested.Results: no fault was found with the mr850 humidifier, the 900mr806 heater wire adaptor and the 900mr869 temperature / flow probe.The performance test results were all within specifications, as per the f&p mr850 respiratory humidifier technical manual.In addition, upon receipt of the reported event, an f&p field representative immediately contacted técnica electo medica s.A (the distributor) to obtain further information about the reported event.Técnica electo medica s.A conducted a functional check on the complaint mr850 humidifier as per technical manual and no fault found was found with the mr850 used at the time of the incident.Conclusion: we are unable to confirm the reported event.The hospital was using third party breathing circuit (intersurgical) with the mr850 at the time of the reported event.F&p warns against the use of third party components with our mr850 humidifiers.It was further reported that the f&p patient end temperature probe may not have been getting fully inserted into the non-f&p intersurgical breathing circuit connector.The interactions between the various components, namely the humidifier, the sensing probes, the chamber and the circuits are critical to ensuring safe and efficacious delivery of the therapy.The warning contained in the mr850 user instructions and printed on f&p humidifiers states the following: "the use of breathing circuits, chambers or other accessories which are not approved by fisher & paykel healthcare may impair performance or compromise safety".The mr850 humidification system has many means of protective measures, in particular there is a high temperature alarm, which is generated if the airway temperature exceeds 43°c.The displayed temperature is an indication of the dew point of the gas, and hence the thermal energy associated.If this high temperature alarm is initiated, the humidifier will immediately and automatically shut down all power to the heater wire and the heater plate.The mr850 respiratory humidifier also complies with the requirements specified on the iso 8185 respiratory tract humidifiers for medical use - particular requirements for respiratory humidification systems.This standard contains several requirements relating to the safety and performance of respiratory humidification systems.To prevent thermal injury, the standard also includes maximum enthalpy limits for humidified gas delivered through respiratory humidification systems.The mr850 also complies with the medical devices directive 93/42 eec, annex i "essential requirements".The user instructions provided with the mr850 respiratory humidifier contains the following warning: - ensure that both temperature probes are correctly and securely fitted.Failure to do so may result in temperatures in excess of 41°c being delivered to the patient.- the use of breathing circuits, chambers or other accessories which are not approved by fisher & paykel healthcare may impair performance or compromise safety the mr850 user instructions also state: - push the chamber probe and airway probe into the breathing circuit.Make sure the chamber probe is correctly located in its key-way and that both probes are pushed home.The user instructions that accompany the 900mr869 temperature probe state: - ensure that connectors are firmly plugged into breathing circuit ports before use.

• Brand Name: RESPIRATORY HUMIDIFIER
• Type of Device: BTT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 7755327
• MDR Text Key: 116198209
• Report Number: 9611451-2018-00655
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: K110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 07/10/2018

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: MR850
• Device Catalogue Number: MR850
• Device Lot Number: 2100158568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2018
• Initial Date Manufacturer Received: 07/10/2018
• Initial Date FDA Received: 08/06/2018
• Supplement Dates Manufacturer Received: 07/10/2018
• Supplement Dates FDA Received: 09/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: F&P 900MR869 TEMPERATURE/FLOW PROBE; F&P 900MR869 TEMPERATURE/FLOW PROBE; F&P BC NASAL PRONGS; F&P BC NASAL PRONGS; F&P BC190 FLEXITRUNK INFANT NASAL TUBING; F&P BC190 FLEXITRUNK INFANT NASAL TUBING; GORRO CPAP; GORRO CPAP; INTERSURGICAL BREATHING CIRCUIT; INTERSURGICAL BREATHING CIRCUIT; F&P 900MR869 TEMPERATURE/FLOW PROBE; F&P BC NASAL PRONGS; F&P BC190 FLEXITRUNK INFANT NASAL TUBING; GORRO CPAP; INTERSURGICAL BREATHING CIRCUIT
• Patient Outcome(s): Hospitalization
• Patient Age: 1 YR