MAUDE Adverse Event Report: ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT; BZE

Model Number RT380

Device Problems Thermal Decomposition of Device (1071); Fire (1245); Sparking (2595); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Date 11/13/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).We are currently undergoing investigation and we will provide a follow up report upon completion of investigation.

Event Description

A distributor reported on behalf of a healthcare facility that a spark occured while using the rt380 adult dual heated evaqua2 breathing circuit, and the fire spread causing part of the tube to burn.The patient received a 15cm x 15cm burn to the upper arm which was assessed by the hospital to be a second to third degree burn.The patient was provided airway support with an ambu bag.Bronschocopy was performed on the patient and no harm was identified.The patient was later reported being in a stable condition.No further consequences were reported.

Event Description

A distributor reported on behalf of a healthcare facility that a spark occured while using the rt380 adult dual heated evaqua2 breathing circuit, causing part of the tube to burn.The patient received a 15cm x 15cm burn to the upper arm which was assessed by the hospital to be a second to third degree burn.The patient was provided airway support with an ambu bag.Bronschocopy was performed on the patient and no harm was identified.The patient was later reported being in a stable condition.No further consequences were reported.

Manufacturer Narrative

(b)(4).Correction: other relevant history: "the patient is no longer on ventilation therapy" amended to "the patient was taken off ventilation therapy subsequent to the event".Method: the complaint: rt380 adult evaqua2 breathing circuit was returned to fisher & paykel healthcare for evaluation, where it was visually inspected and material testing was performed.The lot number of the affected circuit could not be confirmed, however the hospital indicated that batch: 2100856286 (device manufacture date: 19 aug 2019) was in stock at the time of the incident.The mr850 respiratory humidifier, the 900mr869 temperature/flow probe and 900mr805 heater wire adaptor were returned for evaluation.Results: visual inspection of the returned rt380 and the 900mr869 temperature/flow probe confirmed that the circuit and the probe was damaged by the fire.Material testing of the returned circuit confirmed the correct material was used.Visual inspection of the remaining circuit found no manufacturing related defects.The functional and electrical testing of mr850 respiratory humidifier found no fault with the device.The assessment of the 900mr805 heater wire adaptor, showed that adaptor was visibly damaged.Our user instructions advise the user to "visually inspect entire product for damage before use.Discard if damaged" and maintenance should be routinely performed as per product technical manual.We have advised the hospital to check their inventory of heater wire adaptors as per our user instructions.Investigation into this complaint also included interviews with hospital staff, device assessment from the same lot, and review of device manufacturing records and manufacturing process (operator, equipment, measurement, material and environment).Review of the device manufacturing records and process showed that there were no non-conformances associated with the manufacture of the suspected batch.Hospital staff could not recall the location of where the spark had originated.We were also informed that for 1.5 hours (during a weaning trial) the circuit was not connected to the patient however there was insufficient information to confirm whether the ventilator and/or the humidifier were turned off at the time.Our user instructions that accompany the rt380 adult evaqua2 breathing circuit state the following: "do not use heated wire breathing circuits without gas flow.If gas flow is interrupted turn the humidifier off.If the expiratory limb is removed from the circuit for any reason, disconnect it electrically from the humidifier." conclusion: based on our investigation we have not been able to determine the cause of the reported event.Rt380 adult evaqua2 breathing circuits are designed to protect against hazardous situations as per iec 60601-1 and iso 8185.All rt380 adult evaqua2 breathing circuits are visually inspected as well as pressure, flow and resistance tested.Those that fail are rejected.The subject breathing circuits met the required specifications at the time of production.Our user instructions that accompany the rt380 adult evaqua2 breathing circuit state the following: "do not stretch or milk the tubing." "do not soak, wash, sterilize, or reuse this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers." "reuse may result in transmission of infectious substances, interruption to treatment, serious harm or death." "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient." "set appropriate ventilator alarms." "do not use heated wire breathing circuits without gas flow.If gas flow is interrupted turn the humidifier off.If the expiratory limb is removed from the circuit for any reason, disconnect it electrically from the humidifier." our user instructions that accompany the mr850 respiratory humidifier state the following: "use of damaged components or accessories may impair the performance of this device or compromise safety." "this device is not suitable for delivery of flammable anaesthetic mixes or nitrous oxide." "remove any sources of ignition, such as cigarettes, an open flame, or materials which burn or ignite easily at high oxygen concentrations." our user instructions that accompany the 900mr805 heater wire adaptor state the following: "visually inspect entire product for damage before use.Discard if damaged." "failure to perform routine visible damage checks may impair performance or compromise safety." "maintenance should be routinely performed.For further information, refer to the mr850 or hc550 technical manual.".

• Brand Name: ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
• Type of Device: BZE
• MDR Report Key: 9463517
• MDR Text Key: 170652229
• Report Number: 9611451-2019-01186
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• PMA/PMN Number: K122432
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RT380
• Device Catalogue Number: RT380
• Device Lot Number: NP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Date Manufacturer Received: 03/31/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: F&P 900MR805 HEATER WIRE ADAPTOR; F&P 900MR869 TEMPERATURE/FLOW PROBE; F&P MR850 RESPIRATORY HUMIDIFIER; F&P RT019 INSPIRATORY/EXPIRATORY CIRCUIT FILTER; PHILIPS 5 LEAD ECG PATIENT TRUNK CABLE AAMI M1520A; PHILIPS REUSABLE NIBP CUFF M1574A
• Patient Outcome(s): Required Intervention