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The event occurred in usa during treatment.It was reported that while on the patient the cardiohelp pump started to make a ¿rock tumbling¿ noise.Further the noise was paired with significant variability in flow and pressure reading.The customer assumed the this was caused by clots within the oxygenator.The hls set and the cardiohelp device were replaced.No harm to any person has been reported.The affected hls set will be investigated in complaint (b)(4).The cardiohelp device was later primed again.The cardiohelp continued to make a noise and showed significant variability in pressure values.The customer assumed that the cardiohelp device has mechanical issues.The second event during priming will be investigated in cardiohelp complaint# (b)(4).Additional information was received on 2026-01-26 that the hls cable was found defective by the getinge technician.The pressure values changed when the cable was moved around.A new hls cable was sent to the customer.The getinge technician confirmed that the hls cable did not show any signs of physical damage.Further information was received on 2026-01-27 that the noise during treatment occurred on (b)(6) 2026.There was no visible clot within the oxygenator and no pump stop occurred confirmed by the customer.Following patient information was shared: male, 16 years old with 63kg.The customer confirmed that the hls set was seated/inserted correctly into the cardiohelp device, but no re-seating/reinsertion was made.In the beginning of the treatment the anticoagulation bivalirudin was used, then the anticoagulation was off for a few hours and it was changed to heparin.The anticoagulant was administered at the start of the hls set use.Additional information was received on 2026-02-11 from the customer to clarify the events.The first hls set started to make noise on (b)(6) 2026, when the patient was on support since 8 days.The customer stated that the noise was most probable to clots as there were anticoagulation difficulties.This hls set was replaced two days later, on (b)(6) 2026 for a new hls set.On (b)(6) 2026, the second used hls set on the patient, which was primed on the same date as the first hls set, started to make a noise with flow and pressure reading issues.Therefore, the customer made the decision to replace the second hls set, as well as the cardiohelp.This information has also been provided in complaint (b)(4) (mfg number 8010762-2026-0000044).As the hls set is investigated in that complaint.As the cardiohelp device was replaced during treatment, a report is required.A getinge technician was sent for investigation.A new hls cable was ordered for the customer.Further the getinge technician stated that the noise most probably was coming from the discarded hls set.Despite the pressure reading issues due to the defective hls cable there was no further fault on the cardiohelp device.The technician 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 pump stop could be confirmed on the date of event.A similar failure for the defective hls cable was investigated by getinge life cycle engineering (lce) on 2022-11-02.The nature of the error could be traced back to a missing electrical connection within the cable.The root cause for the missing connection is a broken wire within the cable, which is originated from external force.According to the risk analysis following root causes can also lead to the reported failure: - a mechanical damage e.G.Due to too high forces during connection/ disconnection of the cable - broken fiber inside the cable the failure of the flow and noise could not be confirmed while investigating the cardiohelp device by a getinge technician.Therefore the most probable root causes are narrowed down in the medical consultation below.A medical consultation was performed by getinge medical affairs on 2026-02-27 with following conclusion: "probable root causes: 1) pressure variability confirmed root cause: defective hls oxygenator cable causing significant variability in pressure readings.During technical evaluation, the service technician identified that pressure values changed when the hls oxygenator cable was manipulated.After cable replacement, pressure readings stabilized, and no further abnormalities were observed.This establishes a confirmed root cause for the reported pressure variability during both events.2)¿rock tumbling¿ noise during support.Flow disturbances within the hls sets, possibly influenced by reported clotting in the circuit and anticoagulation challenges.(disposable was discarded; cannot be verified technically.) potential decoupling of the hls set centrifugal pump from the pump drive of the cardiohelp console.A temporary mechanical decoupling between the magnetically driven pump head and the console drive unit could theoretically generate abnormal mechanical noise and flow instability.However, no decoupling alarm was reported, and no mechanical malfunction could be reproduced during post-service functional testing.Thrombus formation within the centrifugal pump head.A thrombus located within the pump head could potentially produce abnormal noise and flow disturbances.Such thrombus formation would typically be visually identifiable upon inspection of the disposable pump head during and/or after support.However, no such thrombus was reported by the complaint narrative.As the disposable was discarded, this potential cause cannot be technically excluded but is not supported by the available information.Influence of pressure-based intervention thresholds secondary to erratic pressure measurements caused by the defective hls oxygenator cable.Erratic pressure readings may have triggered system responses or pump speed adjustments within set safety thresholds, potentially contributing to significant flow fluctuations and associated acoustic changes.Given that the defective pressure cable was confirmed to produce fluctuations in pressure values, it is plausible that inaccurate pressure feedback may have influenced pump regulation behavior.No additional detailed system log data or further technical information was provided by the customer to allow confirmation of this mechanism.Potential risk to patient-risk of compromised flow stability during ecmo support.Flow variability during support may theoretically affect hemodynamic stability or gas exchange efficiency.However, no adverse clinical consequence was reported.-risk of inaccurate pressure monitoring.A defective pressure cable may result in unstable displayed pressure values, potentially complicating clinical interpretation.In addition, erratic pressure readings may interact with user-defined pressure intervention thresholds.If such thresholds were configured and activated by the customer, falsely elevated or fluctuating pressure values could have been interpreted by the system as threshold exceedances, potentially triggering automatic pump flow adjustments or transient flow reductions.This mechanism may have contributed to the observed flow variability.-risk associated with circuit clotting.Reported clot formation within the circuit may increase resistance and predispose to circuit exchange.Anticoagulation challenges during treatment likely contributed to thrombotic risk.Nevertheless, the situation was clinically managed, and no embolic event or patient harm was reported.Conclusion: a definitive root cause for the acoustic phenomenon and flow fluctuations during treatment cannot be conclusively determined, as the involved hls sets were discarded and therefore not available for return and further investigation.Without physical inspection or functional testing of the disposables, confirmation or exclusion of clot formation within the oxygenator or pump head is not possible.Although thrombus within the centrifugal pump may have been visually detectable, its presence cannot be fully ruled out based on the available information.Based on the complaint description and technical findings, the most probable contributing factors include flow disturbances within the disposable circuit potentially associated with reported clot formation and anticoagulation instability, and erratic pressure signals generated by the confirmed defective hls oxygenator cable.The unstable pressure readings may have interacted with user-defined pressure intervention thresholds, potentially triggering automatic pump flow adjustments or transient flow variations that could explain the reported significant flow fluctuations and associated noise.Importantly, after replacement of the defective cable, the cardiohelp demonstrated normal and stable operation under controlled test conditions.No further pressure abnormalities, flow instability, or acoustic irregularities were observed, and no intrinsic device malfunction could be reproduced.No adverse patient outcome, or patient harm was reported.The clinical team appropriately managed the situation, including precautionary circuit exchange."according to the instruction for use of the involved disposables (hls set advanced 5.0 / 7.0, hit set advanced 5.0 / 7.0, v2.4, chapter "preparation and installation" and quadrox-ir small adult / adult, chapter "priming the system") the pressure sensors have to be calibrated and checked before priming.Furthermore, the cardiohelp has a flow/bubble sensor and a venous probe to measure and control the blood flow and parameters.If the measured values are above high limit or below low limit of the set limits the system generates a visual and acoustical alarm.Additionally, according to the instruction for use (ifu) of the cardiohelp, chapter "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.In the instructions for use (ifu) of the cardiohelp (chapter "cleaning and disinfection") the cables and the whole device should be cleaned after each use to remove soiling or residual blood.Furthermore, in the ifu chapter "connecting the sensors" it is stated that the sensors must be kept clean.According to the instruction for use (ifu) chapter "connecting the combined flow/bubble sensor" the bubble monitoring function test and flow off-set calibration has to be performed before every use.Thus a defective flow/bubble sensor should be detected prior to use, during priming.In addition as the cardiohelp includes pressure sensors and a venous probe it is able to measure and control the blood flow and parameters.If the measured values are above high limit or below low limit of the set limits the system generates a visual and acoustical alarm.In the ifu chapter "using the emergency drive with the disposable hls retainer" is stated that the emergency drive can be used to manually control the blood flow in case of a failed cardiohelp.In the cardiohelp instructions for use (ifu) chapter "using the emergency drive with the disposable hls retainer" is stated that the emergency drive can be used to manually control the blood flow in case of a failed cardiohelp.In the instruction for use (ifu) is stated that it is necessary to decrease the flow to zero before disconnecting and connecting the disposable to the device.The review of the non-conformities has been performed on 2026-01-28 for the period of 2022-04-14 to 2026-01-23.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 2022-04-14.In addition, a review for potential field actions and capas related to the failure and product in this complaint was performed.This complaint is not in scope of any ongoing field actions and/or capas.Based on the results the reported failure "pressure" could be confirmed.The failure "noise and flow" could not be narrowed down to the cardiohelp device and can therefore not be confirmed.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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