MAUDE Adverse Event Report: BERLIN HEART GMBH EXCOR®; VENTRICULAR (ASSIST) BYPASS

Model Number	P15P-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemolysis (1886)
Date of Event	02/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The site contacted berlin heart gmbh clinical affairs (ca) on 2026-02-27 to report that a patient being supported with an excor blood pump pu valves; 15 ml in/out; ø 9 mm experienced hemolysis on (b)(6) 2026.The patient was previously being supported on va-ecmo and the excor cannulas were implanted with centrimag on (b)(6) 2026.After the switch from the centrimag to excor blood pump on (b)(6) 2026, the ldh level increased.The previous ldh have been below 500 u/l and the value increased to over 1500 u/l for three days from (b)(6) 2026.The patient remains stable.The excor blood pump maintained complete fill and ejection.
Additional Manufacturer Narrative
The excor blood pump pu valves; 15 ml in/out; ø 9 mm, s/n 2530317, is used on the patient from (b)(6) 2026 to date.The event occurred on (b)(6) 2026, which is (3 days) after the pump was placed on the patient.We have reviewed the production records of the excor blood pump s/n (b)(6).This pump was produced according to our specifications.

• Brand Name: EXCOR®
• Common Device Name: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): BERLIN HEART GMBH; wiesenweg 10; berlin, 12247 ; GM 12247
• Manufacturer (Section G): BERLIN HEART GMBH; wiesenweg 10; berlin, 12247 ; GM 12247
• Manufacturer Contact: mary beth tate ; 9391 grogan's mill road; suite a-6; the woodlands, TX 77380 ; 7347092080
• MDR Report Key: 24698519
• Report Number: 3004582654-2026-00018
• Device Sequence Number: 10467440
• Product Code: DSQ
• UDI-Device Identifier: 04260090040157
• UDI-Public: (01)04260090040157(17)280719
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: P160035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 03/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: P15P-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/12/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 12 MO
• Patient Sex: Female
• Patient Weight: 10 KG