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	09/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The excor blood pump pu valves; 15 ml in/out; ø 9 mm; sn (b)(6) is in use on the patient from (b)(6) 2025 until the patient was transitioned to centrimag on (b)(6) 2025.The event occurred on (b)(6) 2025, which is (16 days) after the pump in question was placed on the patient.We have reviewed the production records of the excor blood pump and concluded the pump was produced according to our specifications.
Event or Problem Description
The site contacted berlin heart inc.(bhi) clinical affairs in the weekly update stating that the patient, who was originally supported with an excor blood pump, was transitioned to centrimag on (b)(6) 2025.The site stated that the transition was due to the need for better hemodynamics.The site also stated that the hemolysis value for the patient increased to 3927 mg/dl compared to the pre-ldh value of 1243 mg/dl.According to the site, the excor blood pump maintained complete fill and ejection.

• 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: 23278701
• Report Number: 3004582654-2025-00054
• Device Sequence Number: 15655764
• Product Code: DSQ
• UDI-Device Identifier: 04260090040157
• UDI-Public: (01)04260090040157(17)280503
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Nurse Practitioner
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/13/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/26/2025
• 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: 6 MO
• Patient Sex: Male
• Patient Weight: 6 KG