MAUDE Adverse Event Report: BERLIN HEART GMBH EXCOR®; VENTRICULAR (ASSIST) BYPASS

Model Number	P50P-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemolysis (1886)
Date of Event	06/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The excor blood pump pu valves; 50 ml in/out; ø 9 mm; sn (b)(6) is in use on the patient from (b)(6) 2025 to date.The event occurred on (b)(6) 2025, which is (46 days) after the pump in question was placed on the patient.We have reviewed the production records of the excor blood pump and concluded that the pump was produced according to our specification.
Event or Problem Description
The site contacted berlin heart inc.(bhi) clinical affairs on (b)(6) 2025 to report that the patient being supported with an excor pediatric vad system experienced hemolysis on (b)(6) 2025.The patient had a dialysis catheter placed on (b)(6) 2025 with crrt (continuous renal replacement therapy) started the same day.The patient's ldh and pfhgb levels increased since placement of the dialysis catheter and initiation of crrt.Ldh increased from 730u/l on (b)(6) 2025 to 5823 u/l on (b)(6) 2025.Pfhgb levels increased from 7 mg/dl on (b)(6) 2025 to 265 mg/dl on (b)(6) 2025.According to the site, the excor blood pump maintained complete filling and ejection.The blood pump continues to remain on the patient.

• 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: 22377979
• Report Number: 3004582654-2025-00036
• Device Sequence Number: 4413617
• Product Code: DSQ
• UDI-Device Identifier: 04260090040010
• UDI-Public: (01)04260090040010(17)261130
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 07/01/2025

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: P50P-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: 06/10/2025
• Initial Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/11/2024
• 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: 18 MO
• Patient Sex: Female
• Patient Weight: 8 KG