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It was reported there was disconnection of the arterial ecmo cannula of the neck between the tube system and plastic connector of the arterial cannula.As a result, blood loss and death of the patient was occurred.The product has been requested but not received yet.The product was kept by the police.The legal affairs of getinge is involved in this case to contact local support for the police.The medical review has been finalized with the information available at this moment.According to the review: based on the correspondence and available information the possible root cause of the abrupt disconnection of the hls cannulae from the extracorporeal tubing inflow is attributed to migration of the tubing and subsequent disconnection from the cannulae connector.Contributing factors that may have resulted in a disconnection include incremental and recurrent tension on the tubing/cannulae connection during the seven day support as described above.A temporary kink, or occlusion, of the inflow cannula with associated high circuit pressures, and in combination with tubing migration on the cannulae connector, may have contributed to the outcome.Considering the available data received, it is likely that the patient event/outcome may have been directly related to improper or incomplete securement of the hls cannula to the circuit tubing.The customer did not provided the lot number of the affected hls cannula.Therefore, the production records could not be reviewed.The investigation of the manufacturer is ongoing.H3 other text : 4114.
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The following complaint information was provided to maquet cardiopulmonary: "spontaneous disconnection of the arterial ecmo cannula of the neck (vv system, v.Jug.Internals on the right) between the tube system and plastic connector of the arterial cannula.As a result, blood loss and death of the patient that is incompatible with life.A spontaneous disconnection of this tube connection point is still occurring never occurred, so the question arises whether a material defect could have led to the solution.We do not have material numbers for the tube system, the ecmo system is from maquet (lot oxygenator 3000149353), the cannulas are as follows: 21fr marquet bioline coated arterial hls cannula (neck) 23fr medtronic biomedicus life support (bar, not disconnected)".Covid patient implantation on (b)(6) 2021 at 3:10 p.M., on (b)(6) 2021 at 1:17 a.M., the patient's blood pressure dropped, when the clinic staff entered the room, the tube was detached from the cannula and the patient died.The patient was sedated , intubated and so far circulatory stable.The system was implemented on (b)(6) 2021 at 03.10p.M.The support ended on (b)(6) 2021 at 1.17 a.M.The circuit was not modified by or disconnected and reconnected by the customer.No cardiohelp log files could be provided by the customer.Information about if the cannula was secured on the tubing line by cable ties was not provided by the customer.The product has been requested but was not received by the manufacturer.The product was confiscated and is currently still with the responsible prosecution office.The reported event information was assessed by getinge medical affairs and the following was concluded: "abrupt disconnects during extracorporeal support from all causes have been reported in the literature as a significant cause of morbidity and mortality.The correspondence did not indicate whether the circuit disconnect was witnessed by the clinical staff, nor was there a summary provided that described the sequence of events and the actions taken thereafter that may or may not have been contributory to the outcome.An excerpt from subsection 5.2 safety instructions for extracorporeal circulation from the instructions for use |2.6| g-139|05 includes the following statements: the detachment of unsecured tube connections can lead to blood loss and air embolisms in the patient.Check that tube connections are correctly and securely fastened.Secure all tube connections in the tube system with hose ties.If any complication attributable to the hls cannula arises during the extracorporeal circulation, remove the cannula as quickly as possible.Cannulation may be repeated at another suitable access site, using a new cannula.A disconnect as described would result in rapid exsanguination as a result of immediate loss of circuit resistance through the cannulae as well as a complete loss of vascular afterload at the set motor speed.Although no log files or clinical record were received or retrieved from the cardiohelp hardware, it is possible that no alarms would have been posted by the cardiohelp system until the patient¿s intravascular volume had been significantly and critically compromised.The hemodynamic consequences would be captured on the intensive care hemodynamic monitors however.The reviewer assumes the patient had not been ambulated given the outflow cannulae was in the femoral vein.Stress or tension on the cannulae insertion sites and the tubing/ cannulae connectors are, therefore, not attributed to ambulation.That said, the tubing to cannulae connections are strictly a friction fit interface held in place by three connector barbs.These connections are undertaken as a ¿wet connection¿ with bleed back and de-airing at the junction of these two components.As previously indicated these junctions should be secured with at least one tie band as per the instructions for use.During the seven day course of therapy the patient would have been re-positioned by the critical care staff.Pronation may have also been implemented consistent with that latest treatment modalities recommended for covid 19 patients.The patient may have also self-re-positioned depending on their hemodynamic stability and level of sedation.Re-positioning can result in strain on the cannulas and extracorporeal circuit components.All tubing connections and components require routine and diligent inspection for any signs of leakage and or tubing migration during the course of therapy.Due care must be taken at all times during extracorporeal support to monitor and manage all cannulae insertions sites, the extracorporeal circuit components, and all circuit connections.Tubing and cannulae connections can be damaged, can migrate and/or separate due to incremental and repeated tension on all connections.Frequent assessment of all invasive lines and connection points is advocated throughout the course of therapy.Based on the correspondence and available information the possible root cause of the abrupt disconnection of the hls cannulae from the extracorporeal tubing inflow is attributed to migration of the tubing and subsequent disconnection from the cannulae connector.Contributing factors that may have resulted in a disconnection include incremental and recurrent tension on the tubing/cannulae connection during the seven day support as described above.A temporary kink, or occlusion, of the inflow cannula with associated high circuit pressures, and in combination with tubing migration on the cannulae connector, may have contributed to the outcome.It is possible that no alarms would have been posted by the cardiohelp system until the patient¿s intravascular volume had been significantly and critically compromised.The cardiohelp has no intrinsic ability to monitor the hemodynamic status of the patient nor are these measurements part of the essential performance.The event would normally be captured on the hemodynamic monitors necessary for safe application.It is unclear whether the hemodynamic monitoring alarms would have provided the necessary interval to successfully intervene in this instance.Considering the available data received, it is likely that the patient event/outcome may have been directly related to improper or incomplete securement of the hls cannula to the circuit tubing." two tie bands are provided with the hls cannula disposable set.Ifu (instruction for use) hls cannula g-139, v05, page 9: the detachment of unsecured tube connections can lead to blood loss and air embolisms in the patient.Check that tube connections are correctly and securely fastened.Secure all tube connections in the tube system with hose ties.If any complication attributable to the hls cannula arises during the extracorporeal circulation, remove the cannula as quickly as possible.Cannulation may be repeated at another suitable access site, using a new cannula.Ifu hls cannula g-139, v05, page 10: if the patient is repositioned or transported, there is a risk of decannulation caused by strain on the tubing and mechanical damage.The greatest care should therefore be exercised when carrying out these measures.Ensure that there is no strain on the cannula.Avoid subjecting the cannula to mechanical loads.Keep the device away from magnetic resonance tomographs.If cold solutions are used (e.G., cardioplegic solution), the cannula may be less flexible.Ifu hls cannula g-139, v05, page 12: caution! de-air the cannula carefully.6 carefully remove the cap from the cannula and connect the cannula to the appropriate tube line.Connect the cannula as follows: advance the tube as far as the limit stop on the connector.Position a cable tie on the first ring, approx.5 mm from the connector limit stop, and tighten it using a suitable instrument.Position a second cable tie between the first cable tie and the connector limit stop, and tighten.The eyes of the two cable ties should be opposite each other.Thus the product problem could not be confirmed.The customer will be informed via the getinge sales representative about the investigation results.Timeline for communication of public prosecutors office: 2022-07-04: getinge representative received the file number: (b)(4) of the public prosecutor's office and the treatment documents address.2022-10-06: getinge received new information from (b)(6) public prosecutor's office that getinge could not take any further action and the public prosecutor does not expect any further investigations by getinge.However, getinge continued to support the case.2022-11-25: the public prosecutor has asked the police to conduct follow-up investigations at the hospital.2022-12-14: getinge was informed via getinge legal affairs with the confirmation of use error.2023-01-20: getinge sent a letter to public prosecutor's office with comprehensive evidences as follows: use of cable ties prescribed, further hazard warnings, and also a copies of instruction for use.2023-03-02: the prosecution office informed getinge that the investigative proceedings (ref.(b)(4) have been discontinued by 2023-01-25.The occurrence rate was calculated for the reported failure and product 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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