EXCOR®

Description of Event or Problem

The site contacted Berlin Heart Clinical Affairs (CA) on (b)(6)2026 to report that a patient experienced hemolysis on (b)(6)2026. The patient was originally implanted with the EXCOR cannulae which was connected to a PediMag. On (b)(6)2026 the patient was transitioned from the Pedimag to the Berlin Heart EXCOR pediatric system. Prior to the transition, the patient's baseline LDH level on (b)(6)2026 was 670 U/L, compared to a previous range of approximately 400-600 U/L. Following the transition, the LDH level increased to 946 U/L on (b)(6)2026 and further rose to 1,268 U/L by (b)(6)2026. Plasma free hemoglobin also increased from a baseline of 60mg/dL to 100 mg/dL.The patient was transitioned from the EXCOR system back to PediMag support on (b)(6)2026. During this period, no visible hematuria was observed, and no changes were made to the patient's anticoagulation regimen. The EXCOR blood pump functioned as intended maintaining complete filling and ejection during the period of the use on the EXCOR system.

Additional Manufacturer Narrative

The Blood pump PU valves; 15 mL in/out; Ø 9 mm, S/N (b)(6) was placed on the patient on (b)(6)2026 until the patient was transitioned back to PediMag on (b)(6)2026.The event occurred on (b)(6)2026, which is (2 days) after the pump was placed on the patient, who is being supported with anEXCOR Ikus driving unit.We have reviewed the production records of the EXCOR blood pump. This pump was produced according to our specifications.