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(b)(4).Method: the complaint f&p mr290v vented autofeed humidification chamber (b)(4) was not returned as the device was already discarded by the healthcare facility.The lot number of the complaint chamber could not be provided.However, f&p could identify four batches of mr290v chambers that were sold in the past 12 months ((b)(6) 2017 - (b)(6) 2018) to the healthcare facility where the event occurred.A device history record (dhr) review for all batches was performed and retained samples from the batches were functionally tested.The involved f&p mr850 respiratory humidifier (sn: (b)(4), manufactured 09th january 2009; ps#(b)(4)) (the "mr850 humidifier") was returned to f&p in (b)(4) for investigation.The humidifier unit was externally and internally inspected and an electrical safety test was conducted.A scanning electron microscopy (sem) analysis was performed on the white residue that was found externally and internally on the mr850 humidifier.In addition, all service reports for the past years for the involved mr850 humidifier were reviewed and a review of the dhr for the involved mr850 humidifier was performed.Results: a dhr review for all mr290v batches that were delivered to the healthcare facility during the last 12 months was performed and no issues were identified.All visual, dimensional and functional tests were according to specifications and all training records were complete.Functional tests of retained samples from the batches were performed and the units were all within specification.Visual inspection of the returned f&p mr850 respiratory humidifier revealed that white residue was found on the heater-plate surface, the drain channel (of the humidifier's enclosure), the heaterwire adaptor and the temperature probe socket.Only traces of the white residue were found on the control pcb (low voltage area on the secondary side; max: 15v) of the unit.No traces of residue were found on the power pcb and under the heater plate assembly.The involved mr850 humidifier passed the electrical safety test and the protective earth was still intact.There was no breach between the primary side and secondary side on the power pcb, as no traces of residue were found on the power pcb side.The enclosure and the power cord were not damaged.Sem analysis of the detected white residue on the heater plate and the control pcb revealed that the white powder composed of an aluminium salt and a sodium salt (with the presence of aluminium, carbon, oxygen and sodium).All service records of the involved mr850 humidifier were reviewed and the unit was annually serviced (2013 - 2017) with no fault identified or no fault identified related to the reported event.A dhr review for the involved mr850 humidifier was performed and no issues were found: there was no evidence of any out of specification parameters and all training records were complete.Conclusion: based on our investigation we are unable to determine what may have caused the reported event of an "electrical shock" that the customer had experienced.The healthcare facility reported that bicarbonate of soda was accidently connected to the f&p humidification chamber instead of distilled water.As soon as the error was noticed, the bicarbonate of soda bag was replaced with water, but the chamber that already had some bicarbonate of soda in it, was not replaced.The sem analysis of the white residue on the heater plate and pcb of the involved mr850 humidifier revealed that the residue is aluminium salt and a sodium salt.The results showed the presence of aluminium, carbon, oxygen and sodium.This is consistent with the chamber being filled with a sodium bicarbonate solution, which would most likely decompose at high temperatures and form strongly alkaline salts that potentially could corrode the aluminium chamber base.The involved mr850 humidifier passed the electrical safety test and the protective earth was still intact.Therefore, it is highly unlikely that the user experienced an electrical shock by touching the heater plate.Electricity requires a complete path (circuit) to continuously flow and it would need to breach through the humidifier's insulation (enclosure).A continuous supply of water would be required between the control pcb and the user to create a complete path.The enclosure and the power cord were not damaged and only traces of residue were found on the pcb, which suggests that a continuous supply of water was not present and therefore a complete path (circuit) was not given.Due to limited information from the healthcare facility, there are other environmental factors that have not been considered in this investigation.These include e.G.Other equipment, the integrity of the earthing in the mains system, and electrostatic discharge.Every mr290 chamber is pressure tested following the manufacturing process to check for any leaks present in the chamber dome due to cracks or other causes.Any chamber which fails this test is rejected.In addition, the pressure test is followed by a visual inspection of each chamber.No cracks in the chamber dome are acceptable.Any chamber that fails this inspection is rejected.The subject mr290v chamber would have met the required specification at the time of production.The f&p mr850 respiratory humidifier meets all the relevant standards for safety and performance of iso-8185, including iec 60601-1 and derivatives, which covers electrical safety for medical devices.The mr850 is independently tested by underwriters laboratory inc.(ul) to ensure compliance with the standard.The mr850 has electrical insulation classification of class i protective earth as required by en60601-1.Clause 44 of iso-8185 includes requirements to consider chamber leaks, including spillage and overfilling as part of the risk management of the device.This device has been verified to conform with the standard.The user instruction that accompany the f&p mr290v vented autofeed humidification chamber shows in pictorial form the correct setup of the mr290 chamber with a water bag.The water bag on the picture has the label "h2o" on it, which is the chemical name for water.The user instruction also states in the "attention section": "use usp sterile water for inhalation or equivalent".The user instructions only uses the word "water" when referring to the used liquid for the mr290 chamber (for example, "do not fill the chamber with water in excess of 37c", "do not use the chamber if the water level rises above the maximum water level line", etc.).In addition, the user instruction of the f&p mr290v humidification chamber state the following: - "do not soak, wash, sterilize, or reuse this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers." - "do not use the chamber if the seals are not intact when received, or if it has been dropped".The user instructions that accompany the f&p mr850 respiratory humidifier state in the caution section: - "do not immerse the heater-base or temperature probe electrical connections in any liquid".
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A healthcare facility in (b)(6) reported that by mistake a bag of bicarbonate of soda instead of distilled water was attached to an f&p mr290v vented humidification chamber.It is our understanding that when the hospital staff noticed the error, the bag of bicarbonate of soda was replaced with a distilled water bag, but the chamber was not replaced.The f&p mr290 chamber was used in, in conjunction with an f&p mr850 respiratory humidifier, a carefusion breathing circuit and a covidien tracheal intubation probe.We have been advised that at 6 pm on the day of the incident, a nurse noticed water on the floor and when she put the humidifier in her hands, water dropped on her feet and at this time she experienced an electrical shock.We understand that the nurse has fully recovered after this incident and is back to work.It was further reported that the chamber, involved in the incident, was observed to have cracked and it had a white sediment layer.The chamber was discarded by the hospital.The healthcare facility also informed f&p that a neonate was resuscitated and was stabilized.The patient was pronounced deceased at 8.30 pm (2.5 hours after the incident occurred).Upon receipt of the reported event, an f&p field representative in (b)(6) immediately contacted the customer (the healthcare facility) to obtain further information about the reported event.F&p contacted the customer via email but as incomplete information about the reported event was received, another follow-up was conducted via telephone.Again, insufficient information was received to complete our investigation.F&p met with the head department manager of the healthcare facility where the event occurred, and obtained further information: there was no correlation between the death of the patient and the event.F&p was advised that the neonate patient was admitted to the intensive care department with a malignant whooping cough which we understand is a rare life-threatening illness characterized by severe respiratory failure.We were advised that the patient death was due to a complication with a medical procedure (perforation of a heart ventricle when placing a sensor) in addition to the patient's very sick state.
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