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	04/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The site contacted berlin heart inc.(bhi) clinical affairs on 2025-05-12 to report that the patient being supported with an excor pediatric vad system experienced hemolysis.The patient's ldh levels increased to 2148 u/l and pfhgb 77.6 mg/dl on (b)(6) 2025.The rate on the excor active driving unit was decreased at the time of the event.Repeated lab values showed continued hemolysis and the patient was transitioned to continuous flow on (b)(6) 2025.According to the site, the excor blood pump maintained complete fill and ejection.
Additional Manufacturer Narrative
The excor blood pump pu valves; 10 ml in/out; ø 6 mm; sn (b)(6) was in use on the patient from (b)(6) 2025 until the time of the event on (b)(6) 2025.The pump continued to remain on the patient for a further 7 days until the patient was escalated to continuous flow on (b)(6) 2025.We have reviewed the production records of the excor blood pump and 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: odell roberts ; 9391 grogan's mill road; suite a-6; the woodlands, TX 77380 ; 2818639712
• MDR Report Key: 22070659
• Report Number: 3004582654-2025-00028
• Device Sequence Number: 8702457
• Product Code: DSQ
• UDI-Device Identifier: 04260090040102
• UDI-Public: (01)04260090040102(17)270131
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/22/2025

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: 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: 05/12/2025
• Initial Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/20/2024
• 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: 4 MO
• Patient Sex: Female
• Patient Weight: 5 KG