It was reported that arterial reperfusion line is disconnected during the patient on intensive care unit.The cannula was inserted on 2023-03-20 and the failure occurred on 4th day of usage.Blood loss and unquantified desaturation were occurred on patient.Customer gave 2 unit of blood to make up for lost blood.Sample investigation could not be performed since the product was discarded by customer.The customer did not provide the lot number of the affected product.Therefore, dhr (production records) review could not be performed.Getinge medical affairs conducted a medical review: the event details are described as: ¿a 53 year old patient was treated for an acute coronary syndrome by angioplasty and subsequent stenting.The treatment was complicated by cardiac arrest which required resuscitation via veno-arterial (va)ecmo.Arterial cannula was placed in the left femoral arterial, however no details were provided about placement.On (b)(6) 2023 (around 0430 hrs), it was discovered by nursing services that the arterial cannula was disconnected.The information of whether the arterial cannula disconnected from arterial tubing line or the arterial cannula became disconnected / dislodged from arterial site in the patient were not provided by customer.Further, it was stated by the customer that mobilization (i.E.Movement / repositioning) of the patient was not performed in the course of care (i.E.Up to the time of the event).It is assumed that the patient was clinically stabilized after the administration of the two (2) units of prbcs.Supplementary fluids are assumed to have been administered (along with the prbcs) to aid in volume replenishment of the patient.¿.The related mitigations were stated within this review and are in place in the hls cannulae ifu (instruction for use): caution! if the cannula is not inserted up to the limit stop, it must be fixed in an appropriate way.Caution! attach the cannula securely to the vessel or surrounding tissue to prevent accidental dislocation during the extracorporeal circulation.Caution! if a suture is directly looped around the wire-reinforced section, the cannula can be cut into, kinked or damaged.Secure the cannula around the rigid barbed connectors in such a way as to ensure that it is not kinked at the insertion site.Attach the cannula securely to the vessel.For this purpose, use the removable skin attachment accessory supplied or else a slit at the end of the cannula for the suture material.The removable skin attachment accessory has holes to take the suture material.Caution! check the connection between cannula and tubing set regularly.If and which taken measures were not provided by the customer.However, one of the probable cause of the reported failure according to the medical review has been explained as: inadequate fixation of the cannula to either the connector (via tie bands) or to the patient (via skin attachment accessory) may represent a possible root cause for the disconnection/dislodgment of the cannula as explained in the complaint.Further, it was stated that customer used another manufacturer tubing for the connection which is also found as another possible root cause of the reported failure as: ¿it is not known if the livanova tubing was coated with a substance (coating) that made the connection more slippery than expected or if the tubing caliber was properly mated/sized with the cannula connector.The use of the ¿retroperfusion¿ line (reference no.Ab2118) from livanova may also represent a possible root cause of the event.¿.Due to the lack of information, exact root cause could not be determined during medical review.Besides, the product problem could not be confirmed since there is no sample return for investigation.The customer will not provide further information.Additional to the possible causes assessed by medical affairs, the reported failure was also identified as part of the current risk assessment and control of hls cannulae and the most probable cause is associated to: manufacturing: inappropriate assembly of components.Total failure or impairment due to out-of-spec assembly.Based on the received information and investigation above, the reported failure could be confirmed.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.H3 other text : sample was discarded by customer.
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