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

Model Number	P10P-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemolysis (1886)
Date of Event	03/05/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The blood pump pu valves; 10 ml in/out; ø 6 mm, s/n (b)(6) was used on the patient from (b)(6) 2026 until the pump was replaced on (b)(6) 2026.The event occurred on (b)(6) 2026, which is (48 days) after the pump was placed on the patient, who is being supported with an excor ikus driving unit.We have reviewed the production records of the excor blood pump.This pump was produced according to our specifications.
Event or Problem Description
The site contacted berlin heart clinical affairs (ca) on (b)(6) 2026 to report that a patient experienced increased hemolysis on (b)(6) 2026.The hemolysis values increased to three times the upper limit of normal: ldh from 367 to >1350, pfhgb > 50.The excor blood pump continued to function as intended maintaining complete filling and ejection throughout.No deposits were noted in the pump.

• 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: mary beth tate ; 9391 grogan's mill road; suite a-6; the woodlands, TX 77380 ; 7347092080
• MDR Report Key: 25037563
• Report Number: 3004582654-2026-00026
• Device Sequence Number: 10369900
• Product Code: DSQ
• UDI-Device Identifier: 04260090040102
• UDI-Public: (01)04260090040102(17)280314
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 04/29/2026

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: 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: 03/30/2026
• Initial Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/17/2025
• 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: 4 MO
• Patient Sex: Male
• Patient Weight: 4 KG