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The event occurred in the us.It was reported that a patient was placed on an hls set on (b)(6) 2026.A small amount of blood was leaking on the connection where the 3/8 tube was connected to the inlet connector of the hls module.Due to the small amount of blood loss due to the crack that was noticed, the hls set was exchanged with a new one.During support, no excessive pressures were documented, or adverse conditions with the pump were documented.The hls set was primed and set up on (b)(6) 2026 and at that time no leaking or damage to the set was noticed.The affected hls set is scrapped by the customer and is no longer available for investigation.On 2026-02-03 new information has been provided by the ssu (sales and service unit) as follows: estimated 1000+ ml blood was lost and the patient required a blood transfusion due to the leakage.On 2026-02-23 it was provided that "during the peri-procedural period while the ecmo circuit was clamped, the patient pea arrested.Rosc was achieved within 2 rounds of cpr, but endotracheal intubation and large volume blood resuscitation were required.Post-event, patient was neurologically responsive to command and vital signs and blood gases normalized." the patient data (as age and sex of the patient) was not shared by customer.Due to the information that the patient required a blood transfusion due to the amount of blood loss and the reported cardiac arrest a report is required.The affected hls set is not available for technical investigation as the hls set was discarded by the customer.Therefore, the exact root cause remains unknown.A medical review was performed by getinge medical affairs on 2026-03-03 with following conclusion: "based on the available information, no definitive root cause can be established.The most probable and reasonable contributing factors include mechanical stress to the circuit during clinical handling.The customer confirmed that no difficulties were noted during priming, including air removal, resistance, or abnormal circuit feel, which indicates that the hls set was likely intact immediately after setup.Additionally, the customer reported that leakage was first observed on (b)(6) 2026 at 01:35, suggesting that no leakage was present during or directly after priming.According to the complaint narrative, the patient underwent intra-hospital transport and positional changes, including proning, while on extracorporeal support.According to the instructions for use (ifu), intra-hospital transport and repositioning carry a risk of decannulation, tubing strain, and mechanical damage.Excessive strain on tubing or cables, failure to use recommended holders or accessories, mechanical impact in confined spaces, or kinking of tubes may lead to circuit damage and inadequate patient support.Although no specific incident of circuit dropping, bumping, stretching, or visible tubing tension was reported, the possibility of mechanical stress during transport or patient positioning cannot be fully excluded.The leakage occurred at the junction between the drainage/inlet limb tubing and the hard plastic inlet connector near the venous probe.The ifu states that leakage, air penetration, visible set deposits, or increased pressure drop are indications for set replacement.The customer appropriately clamped the circuit upon identification of active leakage, which is consistent with the ifu recommendation to clamp the circuit in the event of leakage to prevent blood loss and embolism.No evidence of device malfunction or performance degradation prior to the event could be confirmed.However, due to the absence of product return and subsequent technical investigation, a possible material defect, mechanical damage incurred during clinical handling, or damage to the connector or venous probe area cannot be definitively ruled out.Therefore, the exact root cause remains undetermined.There was no documented evidence of user error; however, clinical handling factors such as patient transport and repositioning may have contributed to a hazardous situation by potentially inducing mechanical stress on the circuit components.The general patient condition included severe respiratory failure requiring extracorporeal support for ards.The patient experienced significant blood loss (1000 ml within 30 minutes) secondary to circuit leakage, resulting in severe hypotension and pulseless electrical activity arrest.Nine units of blood products were transfused.The patient subsequently achieved return of spontaneous circulation after two cycles of cardiopulmonary resuscitation and showed neurological responsiveness post resuscitation.The primary hazardous situation was acute circuit leakage leading to rapid intravascular blood loss.Patient harm was related to hemodynamic instability, cardiac arrest, and the need for emergency resuscitation and massive transfusion.Based on the available information, a causal association between the product and the clinical event cannot be conclusively established, but product-related mechanical failure cannot be completely excluded." based on the results and the provided photographical/video evidence provided by the customer, the reported failure "leakage inlet connector" could be confirmed, but the exact root cause of the leakage remains unknown.The production records of the affected product were reviewed on 2026-03-04.According to the final test results, the modules with lot# 3000503842 and 3000503763 passed the tests as per specifications.Production related influences are unlikely.The review of scrap, rework, enhancements, design changes were reviewed an no abnormalities in regards to the reported failure were found.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.The review of the non-conformities has been performed for the reviewed time period.It does not show any non-conformity in regards to the reported product and failure.As stated in the instructions for use (ifu) of the hls set - in chapter preparation and installation ¿perform a careful visual inspection of the device before use.In particular, ensure there is no damage to the material, cracks, burrs or fissures.¿ furthermore, it is stated in chapter priming the system ¿check the device for leaks during priming.Do not use the device if there are any leaks.¿ and ¿before priming the set, run water through the heat exchanger of the hls module advanced and check for leaks.¿ it is also stated in the ifu in chapter safety instructions for intra-hospital patient transport "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.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.Furthermore, it is stated "during intra-hospital patient transport, environmental influences and supply sources for the system change.This can lead to infections and inadequate patient support.The ifu stated in chapter indications for replacing the set replacement of the set can be indicated in the following cases: - leakage - penetration of air - visible deposits in the set - increase in pressure drop 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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