|
|
| Model Number BE-HLS 7050 |
| Device Problem
No Flow (2991)
|
| Patient Problem
Hypovolemia (2243)
|
| Event Date 11/25/2021 |
|
Event Type
Death
|
|
Manufacturer Narrative
|
|
The investigation of the manufacturer is ongoing.
|
| |
|
Event Description
|
|
The following event 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." this report covers the involved maquet hls set.The arterial maquet hls cannula was already covered by complaint # (b)(4).Complaint id: (b)(4).
|
| |
|
Event Description
|
|
Complaint id: (b)(4).
|
| |
|
Manufacturer Narrative
|
|
It was reported there was disconnection of the arterial ecmo cannula of the neck between the tube system (hls set) and plastic connector of the arterial cannula.As a result, blood loss and death of the patient was occurred.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 affected product was requested to be returned for manufacturer's laboratory investigation but was not received yet as it was confiscated by police.The legal affairs department of getinge was involved in this case in order to provide local support for the product release for investigation purposes.However, the reported event information available at this time was assesed 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.A non-exhaustive search of the literature addresses the associated risks of extracorporeal support.Routine assessment and structured formal checklists are published and advocated in international standards (i.E.Elso) (extracorporeal life support organization (elso), 2017) (hamed, alinier, & hassan, 2018) (stentz, wiepking, hodge, ramonell, & jabaley, april 2021 vol 3 number 4).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.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 attributable 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 tie bands.The tubing must be fully advanced on the connector beyond the 3rd bard or ridge that is molded into the connector.The hls set advanced ifu recommends two tie bands with the locking mechanism rotated at 180 degrees.Eight tie bands are provided with the hls set advanced disposable set.During the seven day course of therapy the patient would have been repositioned 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.Any and all of the above conditions can result in tubing migration on the connector over time with the risk increased when tie bands are not applied.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 consistent with the ifu and published guidelines.Tubing and cannulae connections can be damaged, migrate and/or separate due to incremental and repeated tension on all connections.Frequent assessment of all invasive lines and extracorporeal tubing junctions¿ is required 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 of the hls set advance may be 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 critical parameters 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.The set flow and motor speed were not provided by the clinic, and the rate of blood loss cannot be determined.Considering the limited available data, it is likely that the patient event/outcome may have been directly related to improper or incomplete securement of the hls cannula to the hls set advance circuit tubing.Therefore, it is reasonable to assume that root cause is not attributable to the hls set or to the cardiohelp system.Furthermore, the production records of the affected hls set (batch # 3000152184) were reviewed on 2022-03-24.Following steps are performed with a 100 % inspection: mounting of tubing line.Packaging of assembly parts ( cable ties) and control.Final product check.According to the final test results, all hls sets passed the tests as per specifications.Production related influences are unlikely to have contributed to the reported failure.The investigation of the manufacturer is ongoing.
|
| |
|
Event Description
|
|
Complaint id: (b)(4).
|
| |
|
Manufacturer Narrative
|
|
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)" the system was implemented on 2021-11-18 at 03.10p.M.The support ended on 2021-11-25 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 affected hls cannula was handled within complaint record # (b)(4).A picture 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 bochum.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." eight tie bands are provided with the hls advanced disposable set.The ifu hls set advanced, g-360 v04 is stating the following: page 13: 5.2 safety instructions for the extracorporeal circulation mechanical forces may act on the components during the application.Unsecured tube connections can come loose.This can lead to blood loss, embolisms and inadequate patient support.Attach the tube connections correctly and securely.Secure all tube connections in the tube system with two cable ties rotated 180°.Secure all connections.Avoid excessive tension and check the integrity and leak-tightness of the components immediately.Page 21: 7.3 connecting to the patient 1 open the table set bowl.The person working under sterile conditions clamps the red [2] and blue [1] tubes close to the clamp symbol using the clamps in the bowl and connects the red [2] and blue [1] lines of the table set by disconnecting the quick-action couplings.The sterile table set can now be removed from the table set bowl.2 cut off the quick-action couplings [3].3 connect the set to the cannulae air-free.Make sure that the cannulae are connected to the correct tube ends.4 secure the tube connections between the set and cannulae using cable ties.Page 16: 5.4 safety instructions for patient transportation if the patient is repositioned or transported, there is a risk of decannulation caused by strain on the tubing and mechanical damage.This can lead to inadequate patient support.Use the recommended holders and secure them close to the patient.Do not carry the system in your hand during application.Use the recommended accessories to secure it to the bed or other modes of transportation.Do not allow tubes or cables to hang down.Ensure that there is no strain on tubes or cables.Avoid mechanical impacts and knocks, particularly in confined spaces, such as doorways and elevators.Avoid kinking tubes or cables.Thus the reported failure "spontaneous disconnection of the cannula" could not be confirmed.The customer will be informed via the getinge sales representative about the investigation results.The occurrence rate regarding the above complaint is below the acceptance rate.Thus, no remedial action 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.
|
| |
|
Search Alerts/Recalls
|
|
|
