MAUDE Adverse Event Report: RESPIRATORY HUMIDIFIER; BTT

Model Number F&P 950

Device Problems Device Alarm System (1012); Misconnection (1399)

Patient Problem Hypothermia (1915)

Event Date 12/16/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The f&p 950 respiratory humidifier is not currently available for sale in the united states.The f&p mr850 respiratory humidifier is an equivalent device currently on the market in the us.We are currently in the process of obtaining further information to determine if fisher & paykel healthcare's product caused or contributed to the reported event.We will provide a follow up report upon the completion of our investigation.

Event Description

A healthcare facility in (b)(4) reported via a fisher & paykel healthcare (f&p) field representative that the f&p 950 respiratory humidifier did not alarm when it was set up with a ventilator such that the gas flowed in a reverse direction through the humidifier.The hospital stated that "a 24-week preterm infant had been receiving cpap through the ventilator for at least four hours before the mistake was rectified".The customer further noted that "this incident was not a result of faulty equipment or lack of training provided by the company".The hospital continued to use the complaint 950 device after the reported event, as there was no alleged malfunction with the device reported.The hospital informed f&p that the patient became "extremely hypothermic".Despite the caregiver trying to increase the patient's temperature, the fingers of the patient became necrotic which resulted in the removal of one finger.The customer confirmed that the outcome was not directly attributed to the incorrect set up itself and no further comment was made on it.

Manufacturer Narrative

(b)(4).The f&p 950 respiratory humidifier is not currently available for sale in the united states.The f&p mr850 respiratory humidifier is an equivalent device currently on the market in the us.Method: the complaint device was not returned to fisher & paykel healthcare (f&p) for evaluation as there was no reported malfunction with the device and therefore the device was placed back in service after the event happened.No further information regarding the complaint device such as device lot number and the device log were provided by the hospital.This investigation is thus based on information provided by the customer and our knowledge on the product.Results: the customer reported that the f&p 950 respiratory humidifier was incorrectly connected to the ventilator by hospital staff.The inspiratory breathing circuit and expiratory breathing circuit connections at the ventilator were connected the wrong way around.Conclusion: the hospital reported that the patient was extremely hypothermic (33.5 °c) on admission to the nicu.Due to the lack of heated respiratory humidification caused by the user error, the benefit of body temperature stabilisation in preterm infants from heated humidification could not occur.No direct relationship exists between hypothermia and necrosis and subsequent loss of a digit.Multiple clinical variables would need to occur simultaneously in order for necrosis to take place.Respiratory humidifiers are part of the ventilation system which deliver medical gases to mechanically ventilated patients.The f&p 950 respiratory humidifier comply with iso 80601-2-12:2011 (essential performance to ventilators) and iso 5356-1:2015 (breathing circuits conical connectors).The hospital reported that the neonatal was receiving cpap through the draeger babylog® vn500 ventilator.This ventilator has identical 11 mm taper for both inlet and outlet connection.Due to this, the prevention of reversed connections is highly user dependent.The risk control measure implemented is information for safety.All neonatal breathing circuit user instructions have step by step instructive diagrams of the correct set up regarding this situation.The local f&p field representative visited the subject hospital and provided additional support regarding equipment set up in line with user instructions.

Event Description

A healthcare facility in australia reported via a fisher & paykel healthcare (f&p) field representative that the f&p 950 respiratory humidifier did not alarm when it was incorrectly set up with a ventilator (hospital staff connected inspiratory limb and expiratory limb in reverse) such that the gas flowed in a reverse direction through the humidifier.The hospital stated that "a 24-week preterm infant had been receiving cpap through the ventilator for at least four hours before the mistake was rectified".The customer further noted that "this incident was not a result of faulty equipment or lack of training provided by the company".The hospital continued to use the complaint 950 device after the reported event, as there was no alleged malfunction with the device reported.The hospital informed f&p that the patient became "extremely hypothermic".After the mistake was rectified, the patient's core temperature recovered.Despite the caregiver increasing patient's temperature, the fingers of the patient became necrotic which resulted in the removal of one finger.The customer confirmed that the outcome was not directly attributed to the incorrect set up itself and no further comment was made on it.

• Brand Name: RESPIRATORY HUMIDIFIER
• Type of Device: BTT
• MDR Report Key: 9767661
• MDR Text Key: 183169136
• Report Number: 9611451-2020-00219
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: F&P 950
• Device Catalogue Number: F&P 950
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: 950N80 F&P BREATHING CIRCUIT; 950N80 F&P BREATHING CIRCUIT; VENTILATOR DRAGER VN500; VENTILATOR DRAGER VN500
• Patient Outcome(s): Required Intervention
• Patient Age: 24 WK