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It was reported that the cannula/connector disconnected at a manufacturer bonded connection.The patient expired due to exsanguination.New information received on 2024-02-12 that the complaint#(b)(4) device cardiohelp is the same event as the complaint# (b)(4) device: avalon cannula.There was a profuse bleeding from the avalon cannulation site.The patient expired due to a significant blood loose from the positive pressure/infusion side of the avalon cannula, where the bonded connection had become separated.On 2024-02-16 the information was received that the incident occurred while the patient was already connected to the pump on treatment day 10.The affected 10027-ce#avalon elite 27f was technically investigated at the laboratory of maquet cardiopulmonary with the following results: during the investigation the reported problem could be confirmed.On the connector (non-barbed side) as well as the cannula body (inside), glue residues can be visually detected by an opaque and rough surface with a bead of hardened adhesive.A missing spot on the connector was observed.A defect from injection molding (before assembly) or a collision on the ground/surgical desk of the (already disconnected) tubing set side while the patient application, can be assumed but not definitely clarified.Even though, this small defect on the gluing area is not expected to have a huge impact on the mechanical strength of the connection and is not considered as an origin for the complaint.Since there are no excessive/remarkable mechanical deformations on the connector and the cannula body detectable, it can be excluded that the connector separated from the cannula body due to high external mechanical forces.However, the supplier nordson noticed in their internal investigation, that there are ¿clear¿ indications of stress/compression marks on the connector and cannula body.After their assessment this may resulted from mishandling of the cannula and physical damage to the connector.Taking into consideration that in the complaint it was reported that the incident happened on day 10 of the application, it has been evaluated if the gluing was negatively influenced during patient treatment e.G.Wound treatment.Therefore small movements with the cannula was performed to simulate e.G.Patient positioning (without taking body temperature into consideration).After two to three applications of sanitizer by the spray bottle, the connection showed first signs of ¿separation¿ after about 20-30 minutes of the explorative test.After a manual check of the connection strength, the connector could be disconnected (by hand; without high mechanical effort) from the cannula.Comparing the connector (gluing area) and cannula body (inside) in figure 12 (see invest.Report) , the surface and the gluing residues appear comparable to the images provided from the lab investigation.Based on the investigation results available at this time the exact root cause could not be determined but most probably narrowed down to an operator failure due to the usage of ¿solvent¿ fluids during patient care treatment on the cannula which lead to the separation of the cannula assembly.According to the ifu warning, the usage of ethanol-based solvents on the cannula for cleaning or as lubricant is prohibited.According to the instructions for use avalon elite® bi-caval dual lumen catheter g-185 chapter 5.3 safety information for catheter: - do not use any alcohol or alcohol-based liquids as a lubricant or cleaning agent.A medical review was performed by getinge medical affairs on 2024-04-18 and the situation was reconstructed.The complaint describes a patient, with an underlying interstitial lung disease suffering from worsening hypoxia.On the 21st of november 2023 she was implanted with an avalon elite double lumen canula to facilitate veno-venous extracorporeal circulation as a bridge to lungtransplantation.Upon disconnection at the connector on the return limb of the utilized canula, the patient expired due to rapid exsanguination on 1st december 2023.According to the complaint narrative and the answers to the questionnaire, the event occurred at 02:56 hours a.M.Local time and the patient was declared deceased at 02:58 a.M.In the early hours of the morning on 1st december 2023 the connector on the return limb of the avalon canula disconnected from the canula body.At a flow of ~3,9 lpm, with correspondingly high venous suction (-130mmhg), as documented the evening prior, the patient¿s intravascular volume would be pumped into the room rapidly.While the return limb on the canula, now open to the atmosphere, simultaneously may have entrained air into the right atrium and venae cava, due to the negative pressure in the venous line.After a short, yet undetermined time, air could be aspirated into the venous line and then, in absence of a venous bubble sensor and passage through the hls-oxygenator module, detected by the arterial flow-bubble sensor triggering the arterial bubble intervention and stopping the pump.The pump-stop however would not have stopped further exsanguination of blood as centrifugal pumps are non-occlusive.After four minutes the cardiohelp logged the transition to the emergency mode, which disables any intervention and restarts the pump, as seen with the re-occurrence of the arterial bubble alarm (internally logged time 04:08:21) which would no longer trigger a pump-stop.When the on call perfusionist entered the icu at around 03:20 the patient had already expired and the cardiohelp console was switched off.¿the device was actually switched off before dec 1st @ 03:20, which was when the call perfusionist arrived in the icu (it was turned off after the patient was declared deceased)¿.At or about 03:45 the console was started up in an attempt to access the alarm history (¿it was turned back on shortly after this (~03:45) to see if alarms were present¿).This process was repeated at or about 09:00 hours again by other perfusionists with the same intent (¿the console was again switched on dec 1st @ ~09:00 by other perfusionists to attempt to check alarms again.¿).With the logfiles being non-accessible, in absence of a deliberately started recording prior to switching the device off, an initial complaint (mcp complaint #941042) was created on december 5th for the customer¿s internal investigation: ¿we have to get the logs out from the device as part of investigation and would like to do at the site as per management.¿.On the 1st of february 2024 the complaint concerning the defective avalon canula was communicated to getinge, requiring this review.The disposables, initially implanted on (b)(6) 2023, were sent to the getinge laboratory in hechingen, germany for analysis, where they arrived on the 29th of february 2024.Life cycle engineering processed the disposables received and confirmed the disconnection present at the glued connection site of the return (pressurized) limb of the canula as can be observed.The disconnection of the bonded connector was confirmed by life-cycle-engineering and possible root causes investigated.The canula manufacturer contributed with their own investigation.Conclusion: the complaint narrative describes a patient on the 10th day of veno-venous support, resting or sleeping in bed and, upon reported disconnection of the pressurized return limb from the canula, expiring due to rapid exsanguination.A probable root cause for this could be reproduced due to dissolving of the bonding agent in the canula body, by interaction with an alcohol-based disinfectant.A confounder in the investigation of events and reactions was the difference in logged times as well as the duration of the event as is logged by the user and service logfiles of the cardiohelp.From the answers to the questionnaire and the logfiles it was attempted to establish a reference-timeline to identify details in the sequence of events.It is likely that the reported disconnection at the return port of the avalon-canula was initially undetected.The patient was awaiting lung transplantation secondary to interstitial lung disease and pulmonary hypertension.After the support initiation on the 21st of november, the treatment course went largely uneventful, as can be seen by the relatively few entries in the user log.The last entry being a change in flow limit on the morning seven days prior.After disconnection of the pressure limb, it is assumed that the pump head continued to rotate, generating a flow of about 3.9 lpm.As the return channel in the canula was now open to atmosphere, the suction in the venous vascular system might have entrained incremental amounts of air, that were aspirated into the venous line.The service log-files show no venous air bubble alarm, suggesting that the optional venous bubble sensor was not deployed.Thus, no venous bubble intervention was available to stop the extracorporeal pump in the presence of air in the venous line.It is assumed that bubbles/air passed through the cardiohelp module to the arterial flow bubble sensor which detected the presence of air-bubbles and triggered the intervention linked to the ¿arterial bubble alarm¿.At this point, the pump stopped, giving an acoustic as well as visible alarm.The amount of blood lost in that time cannot be determined accurately.Additionally, depending on the mode of securing the tubing to the patient, it is possible that further exsanguination occurred after the pump stop.Exsanguination is assumed if the loose return tubing-line were suspended below the level of the drainage ports of the canula because of the non-occlusive of centrifugal pump, the blood would follow a hydrostatic gradient/siphon that may have been created.The resuscitative efforts see their first action logged by the cardiohelp in the switch to the emergency modei.E.,4:01 minutes after the initial arterial bubble alarm.This is presumed to coincide with the time of event provided by the customer at 02:56.The patient was declared at 02:58, local time.As stated in the questionnaire, the on-call perfusionist entered the icu at about 03:20, finding the cardiohelp already turned off after termination of resuscitative efforts.The time of resuscitative is given as two minutes, with the cardiohelp, presumably, being turned off at the end of the effort.However, the service log of the cardiohelp shows a resolution of the arterial bubble of approximately twelve (12) minutes after the switch to the emergency mode.The startup of the console to access the alarm log, stated to have happened at about 03:45, roughly 50 minutes after the event at 02:56 local time, is logged 100 minutes after the initial alarm.The getinge lab investigated the returned product, supported by the canula manufacturer, and determined two possible root causes.Visible damages on the canula, that might represent mechanical stress markers on the canula-body and the connector, in presence of adhesive residue inside the canula body, and the force required to disconnect the bonded connection, were deemed unlikely to have caused the spontaneous detachment of the connector from the canula body.The possible application of ethanol-based topical disinfectant was deemed to represent the most likely root cause for the observed disconnection.Experimental reproducibility with another avalon canula could demonstrate that: ¿after two to three applications of sanitizer by the spray bottle, the connection showed first signs of ¿separation¿ after about 20-30 minutes of the explorative test.¿ after a manual check of the connection strength, the connector could be disconnected (by hand; without high mechanical effort) from the cannula¿.This implies that even slight movement, such as can occur during sleep, could have been sufficient to cause the connector to disconnect from the canula body.The lce-investigation thus concludes: ¿the probable root cause is therefore assumed as an operator failure due to the usage of ¿solvent¿ fluids during patient care treatment on the cannula which lead to the separation of the cannula assembly.¿ the source of the small force required to cause the disconnection cannot be determined.Whether it was movement from the patient during sleep, the weight of the tubing exerting force upon the connection site or other conceivable reasons remains unclear.A pre-existing, production related defect of the implanted canula was ruled out as a likely root cause, as ¿no non-conformances¿ of the canula lot (#349133) are reported by the canula¿s manufacturer and the adhesive residue in the defective canula is similar to the reproducible results, implying that the canula correctly passed all performed quality checks during production.The ifu for the avalon elite double lumen canula contains warnings towards tube disconnections, mechanical forces acting upon the components and to not use alcohol or alcohol-based substances.During treatment of any patient on an intensive care unit, it is conceivable that during a dressing change an alcohol based disinfectant is employed to either clean the skin around the canulation site or to dissolve the adhesive of bandages for increased patient comfort.Provided that an alcohol-based disinfectant was used, the lce proposal may have been the precipitating root cause of cannula detachment, thereby leading to the patient¿s expiration from rapid exsanguination.According to the lce-report and the most likely chain of events a clear association of the reported event does not appear to be linked to a production -related root cause of the reported event.This complaint was found in the database of customer complaints for the 10027-ce#avalon elite 27f as a single event (timeframe from 2023-01-31 till 2022-01-31).The customer will be informed about the results by the getinge sales and service unit.The occurrence rate was calculated for the reported issue and it was determined that this is not a systemic issue.Therefore, no remedial action is required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿ s trending program and additional investigations or corrections will be implemented in case of adverse trending.
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