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It was reported that there was a loss of blood flow.The nurse heard a ¿thud/thump¿ and something that sounded like an increasing in the rpm from the cardio-help device.Consequently, the patient suffered an acute desaturation, becoming bradycardic and eventually asystole.The customer was able to establish the flow of approximate 3.8l/min.There were no kinks in the line, no clots in the oxygenator and no cannula migration.The hls set was exchanged during treatment.The patient stabilized, flow established, and saturation improved.The hls set will be investigated in complaint# (b)(4) (mfg report number 8010762-2023-00389).A getinge field service technician (fst) was sent for investigation and repair on 2023-08-15.The hls cable was corroded, and the customer was asked to replace it.The corroded hls cable has not affected the device function and was discarded.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.The log files of the reported cardiohelp device were reviewed and no failure could be confirmed.Further the customer was informed by getinge service and sales (ssu) unit that if the issue reoccurred to call the ssu fst directly before turning the cardiohelp device off.There is a live recording option that the users can perform and save to a usb.This saves the user pressure settings, etc.The instructions for this is in the user manual.This step creates a data file which can be export to usb with extension.This file records all the user-setting data during the operation.However, if the data of this day is not saved then the cardiohelp device resets if it is used again.This is not a fault log- it is an user setting, so if it will be not captured, there are still logs to fall back to.The affected hls set was investigated by the getinge laboratory, and the failure could not be reproduced.As the failure of the flow was not reproducible on the cardiohelp device, the exact root cause remains unknown.However, according to the risk file of the cardiohelp device the following root causes can lead to the reported failure: unexpected no or low rpm by flow intervention due to: malfunction of flow sensor and/or upper flow intervention too low another disposable connection cable (hls cable) with the same failure was investigated by getinge life cycle engineering on 2021-03-31.Deposit and oxides were found on the cable socket.By wetting the socket plane with salt-containing liquids (priming), the measurement signals were influenced by the electrical conductivity of the contamination.A service bulletin was published may 2021 to make the users aware that the contacts of the plug connections must not come into contact with cleaning agents, disinfectants or priming liquid.A medical review was performed by getinge medical affairs on 2023-11-29 with following conclusion: "the customer questionnaire reported that the patient was administered bilvalirudin (0.075 mcg/kg/hr) during support as an anticoagulant/direct thrombin inhibitor (dti).However, no details were divulged as to why bilvalirudin was chosen over heparin.It is assumed that the choice of bilvalirudin may have been chosen due to heparin induced thrombocytopenia (hit) or similar coagulatory/hematologic pathology, but no background behind the choice of the dti was provided by the customer.The d-dimers reported by the customer were 2.21 ng/ml which is a signal for clotting.However, the elevated d-dimers may not have been sufficient to signal thrombus formation in the membrane.Calculation of o2 transfer across the membrane is unable to be performed due to the lack of an svo2 in the customer questionnaire.A low o2 transfer value may indicate the presence of thrombus in the membrane relative to the o2 transfer (and implied co2 removal) due to the reduction of available membrane area.Regardless, the d-dimer values reported by the customer appears to signal the presence of forming/active thrombus.One possible root cause of the event reported by the customer (¿thud¿) may have been the acute aspiration of thrombus (e.G., deep vein thrombus) from the patient into the centrifugal pump rotor.This may explain the "thud/thump" that was accompanied with the corresponding rpm whirring heard by the attending clinician.A second possible root cause of the event may have been associated with hypovolemia and/or inflow cannula restriction.Cannula restriction may have manifested as adherence to the vessel wall and then detachment upon administration of intravenous fluids.Fluid administration may explain the elevation in blood pressure, decrease in pven, decrease in rpms and increase in blood flow post event.That said, few details were provided by the customer, so a definitive analysis is not able to be performed.According to a study by moffett and teruya, aptts are ¿poorly correlated with other tests of dti activity¿, unlike ecarin clotting time.Therefore, measurement of aptt alone may not have adequately reflected the condition/status of a dti to prevent thrombin formation.This may lend support to either a possible patient-related or an anticoagulation-related root cause.As a note, no mention of dti testing was made in either the complaint narrative or the follow-up questionnaire; therefore, it is assumed that no dti testing for (e.G., ecarin clotting time) was performed.The service report stated that the cardiohelp console passed function testing.Further, the getinge investigation of the disposable lead to the following conclusion "it should be noted that the flow reduction complained about by the customer cannot be confirmed from a technical perspective.None of the tests carried out revealed a reduction in flow through the hls module.The condition of the associated tubing set / hose system could not be checked and taken into account during the test.Any damage such as kinks or other deviations can, under certain circumstances, result in a reduction in flow in the system or have a negative impact on the flow." therefore, it is challenging to assign a root cause of the event to the product.If the kink-guard was removed, kinking, or bending, of the tubing directly before the inlet of the disposable may have contributed to a low flow state thereby creating an environment for thrombus formation.Barring more evidence from the customer regarding the event, the possible root cause for the event explained by the customer may be more likely patient-related than product-related.Last, a clot/thrombus in the pump rotor of the hls disposable would have affected the ability of the pump drive to maintain adequate blood flow, which likely led to the acute desaturation explained by the customer (i.E., barring the contribution of patient comorbidities to an acute desaturation)." according to the instruction for use (ifu) of the cardiohelp, chapter 5.3 "connection the sensors", it is stated to ensure that the connected sensors are not defective and to not use if there is a visible damage.The review of the non-conformities has been performed on 2023-09-26 for the period of 2015-11-25 to 2023-08-08.It does not show any non-conformity in regard to the reported product and failures.There is no indication that manufacturing issues occurred during this time, thus production related influences are unlikely.The device was manufactured on 2015-11-25.Based on the results the reported failure "hls cable corroded" could be confirmed and the reported failure "loss of blood flow" could be confirmed but was not device related.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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