MAUDE Adverse Event Report: Berlin Heart GmbH EXCOR®; Ventricular (Assist) Bypass

Model Number	P10P-001
Medical Device Problem Code	Intravalvular regurgitation (4068)
Health Effect - Clinical Code	Hemolysis (1886)
Date of Event	09/09/2026
Type of Reportable Event	Malfunction

• Brand Name: EXCOR®
• Common Device Name: Ventricular (Assist) Bypass
• Manufacturer (Section D): Berlin Heart GmbH; wiesenweg 10; berlin, deu 12247 ; GM 12247
• Manufacturer (Section G): Berlin Heart GmbH; wiesenweg 10; berlin, deu 12247 ; GM 12247
• Manufacturer Contact: luis avila ; 9391 grogan's mill road; suite a-6; the woodlands, TX 77380 ; +1(281)863-9712
• MDR Report Key: 50938599
• Report Number: 3004582654-2026-00052
• Device Sequence Number: 10734942
• Product Code: DSQ
• UDI-Device Identifier: 04260090040102
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Replace
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: P10P-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: 09/09/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/19/2024
• 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
• Patient Age: 8 MO
• Patient Sex: Female
• Patient Weight: 11 LB