The site contacted berlin heart inc.On (b)(6)2021 to report that a patient being supported with an excor blood pump in the lvad configuration experienced a massive bleeding event on (b)(6) 2021.The site reported that the grandmother raised the patient from a lying to a sitting position in the patient´s bed and noticed a sudden appearance of a large amount of blood.The medical teams immediately came to the bedside but were not able to determine the source of the bleeding.A code was called and the patient was volume resuscitated.The attending physician tried to hand pump the device with no success as the patient had not enough intravascular volume.The excor cannulas were clamped off and the medical team emergently placed the child on ecmo for volume replacement and circulatory support.When ecmo was initiated, the attending physician found a breach in the arterial cannula at the junction to the connecting set.The site reported when they called on (b)(6) 2021 that the patient was being supported on ecmo, with the excor blood pump cannulas still connected to the patient but clamped off, but that the exsanguination event led to a severe cerebral and intestinal hypoxic injury, documented by imaging, and that care was being withdrawn due to the patient´s poor prognosis.
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On august 23, 2021, the affected cannula, including the connector set and the connected blood pump, was returned for analysis.The analysis consisted of several high-resolution ct scans, which were carried out by a specialized laboratory.The cannula was initially examined as it was received by berlin heart, then after cleaning and finally in a dismantled condition.All investigation steps were carried out under the supervision of an independent observer and documented by him.Observations: a breach of the cannula was identified about 5-6 mm long.The breach was located above the edge of the connector, under the edge of the first cable tie.The connector edge and the cannula show no deviations from the specifications.The position of the rupture was oriented to the patient's body.At the time of the investigation, the position of the first cable tie was not according to the ifu.At the time of the investigation, the length of the distal end of the cannula, without polyester velour covering, was not according to the ifu.Conclusion: the cannula might have been stretched several times caused by moving the pump upright from the patient's body during routine examination of the blood pump or excessive movement from the patient.This could have led to increased internal material stresses in the silicone of the cannula wall and may have resulted in a breach due to tensile stress.Due to the position of the cable tie and the remaining length of the distal end of the cannula without polyester velour covering, the flexibility of the cannula wall was severely restricted.This could have led to increased internal material stresses in the silicone of the cannula wall and may have contributed to the fracture of the cannula wall due to external kinking and/or tensile stress.
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