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	Brain Injury (2219)
Date of Event	01/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The site contacted berlin heart clinical affairs (ca) on 2026-01-19 to report that on (b)(6) 2026 a pan-scan ct was performed on the patient with blood pump pu valves; 15 ml in/out; ø 9 mm, s/n (b)(6), following blood stream infection and an ischemic cva was incidentally found.The imaging was most consistent with subacute right pca stroke, no movement of visualized fibrin after the event.The patient was originally implanted with only cannulas on (b)(6) 2025 and is being supported with the full excor system since (b)(6) 2025.Since that time, the patient has been suffered from several bacterial and fungal infections.The berlin excor blood pump functioned as intended maintaining full fill and eject.Deposits were noted in the pump before and after the confirmation of cva.
Additional Manufacturer Narrative
The blood pump pu valves; 15 ml in/out; ø 9 mm, s/n (b)(6) was used on the patient from (b)(6) 2025 until the pump was exchanged on (b)(6) 2026.The event occurred on 2026-01-08, which is (10 days) after the pump was placed on the patient being supported with an excor active driving unit.We have reviewed the production records of the excor blood pump.This pump was produced according to our specifications.
Additional Manufacturer Narrative
Incorrect code for investigation findings has been entered inadvertently in the initial report.Therefore, it has been corrected from 3233 to 3221 in section h6.

• 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: 24305092
• Report Number: 3004582654-2026-00008
• Device Sequence Number: 21252410
• Product Code: DSQ
• UDI-Device Identifier: 04260090040157
• UDI-Public: (01)04260090040157(17)280420
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2026

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: 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: 01/19/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/16/2025
• 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