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	Intracranial Hemorrhage (1891)
Date of Event	08/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lvad excor blood pump pu valves; 15 ml in/out; ø 9 mm; sn (b)(6) was in use on the patient from (b)(6) 2025 until the pump was exchanged on (b)(6) 2025.The event occurred on (b)(6) 2025, which is (16 days) after the pump was placed on the patient.We have reviewed the production records of the excor blood pump and the pump was produced according to our specification.
Event or Problem Description
A physician contacted berlin heart gmbh clinical affairs (ca) on (b)(6) 2025 to report that the patient with lvad excor blood pump pu valves; 15 ml in/out; ø 9 mm, had experienced some activity that was suspicious for seizures on (b)(6) 2025.A head ct revealed two subdural hematomas.The patient had episodes with higher blood pressure, coinciding with low-flow episodes.The excor blood pump maintained full filling and ejection at the time of the event.Small fibrin deposits were noted in the pump.According to the update, the patient became stable without seizures, and control ct showed no progression.

• 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: 23097324
• Report Number: 3004582654-2025-00049
• Device Sequence Number: 18448159
• Product Code: DSQ
• UDI-Device Identifier: 04260090040157
• UDI-Public: (01)04260090040157(17)280531
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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): 09/19/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2025
• Initial Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/23/2025
• 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: Male
• Patient Weight: 10 KG