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	Ischemia Stroke (4418)
Date of Event	08/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The site contacted berlin heart inc (bhi) clinical affairs (ca) on 2025-09-25 to report that on (b)(6) 2025 the patient with lvad excor blood pump pu valves; 15 ml in/out; ø 9 mm, was awake, alert, tracking toys and faces and in no apparent distress.The patient's left arm was antigravity with spontaneous movements, more so than the left leg.The right arm, on examination was noted to be plegic without any spontaneous movement even when stimulated with noxious stimuli.The right leg was also noted to be paretic/weak with movements only in the plane of the bed.An electroencephalogram (eeg) performed at the time of the event revealed diffuse slowing and focal slowing over the right and the left centrotemporal regions.No seizures or no epileptiform discharges were noted.The excor blood pump maintained full filling and ejection.Deposits were noted in the pump.
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 pump was exchanged on (b)(6) 2025.The event occurred on 2025-08-12, which is (50 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 specification.

• 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: 23310546
• Report Number: 3004582654-2025-00055
• Device Sequence Number: 12045901
• Product Code: DSQ
• UDI-Device Identifier: 04260090040157
• UDI-Public: (01)04260090040157(17)270906
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Replace
• Type of Report: Initial
• Report Date (Section B): 10/16/2025

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: 09/25/2025
• Initial Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/30/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 12 MO
• Patient Sex: Male
• Patient Weight: 4 KG