|
The customer reported a fire during defibrillation in which the patient sustained 2nd and 3rd degree burns to the right upper shoulder, right upper arm, head, and facial area.The customer further stated the patient developed an extensive lower gi bleed.The facility activated a code hemorrhage as the patient was hypotensive.During that time the patient went into vtach and vfib arrest and a code blue was called concomitantly with the code hemorrhage.The patient was defibrillated five times.On the sixth time there was an observable arc/bright light somewhere between the defibrillation electrode pad, the monitoring pads, and the ekg cables (from another manufacturer) in the area that extended to the patient's upper right shoulder area.It quickly went into a spark then flames which engulfed the patients right upper shoulder, right upper arm, head, and facial area.The fire was put out by the staff in 3-6 seconds and resuscitation continued.The patient was reintubated and the code continued for 40-45 minutes without the return of spontaneous circulation.The patient was pronounced expired.The facility did have photographs taken of the skin impairment.The facility refused to provide the photographs for review.However, the photographs were evaluated by one of the facility's wound care nurses who classified several of the burns as 3rd degree and others as 2nd degree burns.These were located on the upper shoulder clavicular area, right side face, head, and the hair.The customer stated that the patient was a very hairy gentleman.The hair was scorched/burned off his upper body and face.The usual preparations for defibs were done by clipping the hair, not shaving.Since the patient was a stemi, it is the facility's usual and customary practice to place those patients with defib pads due to their high risk of lethal arrhythmias.The patients defib and everything with the code was going as normal.The patient was in a very late presentation stemi with a lot of myocardial damage/cardiogenic shock.There was a check done to make sure nothing was under the pads that might have lifted them and there was nothing noted.There was a 2nd degree burn on the patient in the area of the defib pad over the patients apex.The patient did have an et tube as the patient had been intubated prior to the shocks being started.The ecg cables were engaged to the mrx unit (from another manufacturer).The defib electrode wires were clear from the ekg electrode cables.The pads were placed on the patient anterolateral.The burn on the right clavicle was the result from what appears to have been a melted part of a cable.The customer stated that they do not believe the burns were a contributing cause of the patients death.
|
|
The report was received for product code 22660r with an unknown lot number.Samples of the defibrillation electrodes were not made available as they were lost during the procedure.No pictures of the patient's burns were made available to the cardinal health team, but the burns were described in communication with the client (kaiser).Additional information regarding the event was gathered through an investigation document that was provided by kaiser as well as a conference call with various members of both the kaiser and cardinal health teams.A review of the device history record could not be performed due to no lot number being provided.It should be noted that during production, checks are performed on the wires to ensure they are working properly, these include continuity testing ¿ plug fit test and fgwt (finished goods wire testing) testing as well as aql testing of electricals, shock, pacing, and wire pulls.A review of the incident samples nor representative samples could not be performed as they were not provided as part of the complaint report.During the initial assessment of the photographs provided, there was no visible damage to the defibrillator and the battery was operating as expected.A picture of the 5 wire and 5 electrode ekg cable was provided.Three used snap electrodes were engaged to the clips on three of the five electrodes.The 3 electrodes had hairs over the surface area of each electrode.In the approximate middle of the length of the individual wires, the wires were severely burned, showing black discoloration of the white insulation.In investigating the event, kaiser personnel tested two sets of 22660r electrodes using the defibrillator and a defib analyzer (350-s63264).The first set (lot 930516x) was procured from the carrying case attached to the defibrillator while the second set (lot 025504x) was obtained by materials management.For the first set of electrodes a first test was performed at 20, 50, 100, 150 and 200 joules and registered a ¿pass.¿ a second test on the first set of electrodes was performed at 20, 50, 70, 100 and 200 joules.The tests at 20, 50 and 70 joules registered a ¿pass¿ while the reading output for the 100 joule test initially dropped to 64 joules and passed on retest at 100 joules.The 200 joule test registered a failure of the reading output.An inspection of the pads was performed and discoloration was seen on the apex side electrode.The discoloration had a general partial square shape and was in the center area of the electrode.For the second set of electrodes tested by kaiser personnel (lot 025504x), a first test was performed at 20, 50, 100, 150 and 200 joules, with at least 15 tests performed at 200 joules.The test results registered as ¿pass¿ in all instances.A visual inspection of these pads was performed and showed a round discoloration on the apex electrode in the lower left portion of the silver print area of the electrode.In analyzing the information of the defib analyzer testing performed on the two sets of defibrillation electrodes that were not related to the specific incident, it is important to note that the discoloration of the one electrode is expected.During this testing, the two pads are set up in a manner that the negative charge accumulates on one side while the positive charge accumulates on the other side.Each defibrillation electrode pad is manufactured with a silver pattern printed in the middle of the electrode.During the defib analyzer testing, the energy transfer results in chemical reactions occurring at the metal and hydrogel interface of the electrodes (pads).Defibrillator electrodes convert the electric potential from the defibrillator discharge into ionic potential that is transferred to the patient¿s chest during a defibrillation event or the defib analyzer plates during defib analyzer testing.On cardinal health¿s medi-trace cadence electrodes this electrochemical change arises at the silver-silver chloride (ag/agcl) interface with the hydrogel.Electrochemical reactions driven by the defibrillation voltage occur with water and salt from the hydrogel, plus the silver and silver-chloride forming silver-hydroxide (agoh), among other things.Repeated shocks form higher amounts of agoh presenting the brown appearance on the electrodes.The appearance does not prevent the defibrillation electrodes from meeting their performance requirements.Furthermore, in the defib analyzer testing where there is a reduced contact area of only a portion of the gel-pad versus fully hydrogel area contact on a patient, the current density is greater for the smaller area.Thus, greater potential for agoh generation and accumulation on the cathode resulting in the brown color on that side.Based upon the details provided by the client, the exact root cause of the spark is unknown.Potential root causes were assessed based upon the information that was provided and how the electrodes function.Full engagement of the electrodes to the body of the patient is important to ensure the current density is distributed over the intended surface area of contact.A reduced area of engagement to the body would result in a higher current density in a smaller area.Potential ramifications of such a situation could involve thermal effects (e.G.2nd or 3rd degree burns on skin underlying the electrode).The observed arc flash from the pad to some lower energy state (for example the damaged insulation on ecg wires exposing the shield, or grounded bedrail) presumably occurred due to limited hydrogel contact with the patient due to insufficient hair removal.The arc could have provided an ignition source when combined with air/oxygen and fuel (examples: hair, ecg leadwire insulation, electrode foam cover) and could have caused the fire.It is important to note that an ambu bag was used in conjunction with the intubation.As it was not possible to determine what, if any, manufacturing causes were related to the condition as described, no further actions will be taken at this time.We will continue to monitor for trending of this reported issue.
|
