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	Valvular Insufficiency/ Regurgitation (4449)
Date of Event	11/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient is being supported with an excor pediatric system in bi-vad configuration.The excor blood pump pu valves; 10 ml in/out; ø 6 mm; rvad sn (b)(6) was in use on the patient from 2024-10-18 to date.The affected pump, sn (b)(6) remains on the patient and continues to be monitored.The event occurred on 2024-11-29, (42 days) after the pump was placed on the patient.We have reviewed the production records of the excor blood pump and the pump was produced according to our specification.A detailed investigation report will be provided as soon as it is available.The other pump lvad, sn (b)(6) associated with this event is submitted as 3004582654-2024-00072.The event associated with hemolysis of lvad pump (sn (b)(6) and rvad pump (sn (b)(6) have been submitted as 3004582654-2024-00070 & 3004582654-2024-00071.
Event or Problem Description
A physician contacted berlin heart gmbh clinical affairs to report diastolic regurgitation with thrill on the outlet of both pumps as the ultrasound sonography (usg) showed leaking of the outflow valve.According to the site, the patient had experienced hemolysis since implantation.The patient is transfusion dependent with elevated ldh value.The patient is clinically stable throughout.Bh ca recommended a pump change, however, the site stated that they would closely monitor the patient.The patient is being supported with an excor system in bi-vad configuration.Both pumps are blood pump pu valves; 10 ml in/out; ø 6 mm: lvad (sn (b)(6) and rvad (sn (b)(6) and are still in use on the patient since 2024-10-18.
Additional Manufacturer Narrative
The event occurred on 2024-11-29, which is (42 days) after the pump in question was placed on the patient.The pump continued to remain on the patient for further 79 days from the time of the event until transplantation on (b)(6) 2025.The affected rvad pump was not returned to berlin heart for investigation as the pump was disposed of after transplantation.There was no adverse effect to the patient and that the patient was transplanted without incident.Therefore, neither the exact failure nor the cause of the failure in question could be determined.

• 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: 21027293
• Report Number: 3004582654-2024-00073
• Device Sequence Number: 13023056
• Product Code: DSQ
• UDI-Device Identifier: 04260090040102
• UDI-Public: (01)04260090040102(17)270725
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: P10P-001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/19/2024
• 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
• Patient Age: 5 MO
• Patient Sex: Female
• Patient Weight: 6 KG