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

Model Number	P25P-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemolysis (1886)
Date of Event	04/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The excor blood pump pu valves; 25 ml in/out; ø 9 mm; rvad, sn (b)(6) was in use on the patient from (b)(6) 2025 to date.The pumps remain on the patient and continue to be monitored.The event occurred on (b)(6) 2025, which is (28 days) after the pump 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.The other pump lvad, sn (b)(6) associated with this event is submitted as 3004582654-2025-00032.
Event or Problem Description
The site contacted berlin heart clinical affairs on (b)(6) 2025 to report that the patient supported with the excor system in bi-vad configuration experienced hemolysis.The patient's ldh levels increased to 3000 u/l on (b)(6) 2025.The clinic decided to decrease the rate and the diastolic pressures.The ldh then decreased to 380 u/l as of (b)(6) 2025.There were no visible deposits inside or outside the cannulas.According to the site, the excor blood pumps pu valves; 25 ml in/out; ø 9 mm; lvad, sn (b)(6) and rvad sn (b)(6) maintained complete fill and ejection.

• 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: 22289976
• Report Number: 3004582654-2025-00033
• Device Sequence Number: 8875818
• Product Code: DSQ
• UDI-Device Identifier: 04260090040119
• UDI-Public: (01)04260090040119(17)271201
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 06/19/2025

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: P25P-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: 05/25/2025
• Initial Report FDA Received Date: 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/30/2024
• 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: 3 YR
• Patient Sex: Male
• Patient Weight: 14 KG