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

Model Number	P25P-001X01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	12/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On 2024-12-26, a physician contacted berlin heart gmbh clinical affairs to report that the patient, who was originally implanted on (b)(6) 2024 with excor system in bi-vad configuration, had cardiac tamponade and went to the or on (b)(6) 2024.The site reported that the problem was of high c-reactive protein (crp) and procalcitonin, along with negative cultures.The patient experienced an acute cardiac tamponade secondary to sepsis.The site also reported that there were problems with filling in left excor blood pump pu valves; 25 ml in/out; ø 9 mm; lvad sn (b)(6).Based on the patient's history, the patient received a blood transfusion on (b)(6) 2024 due to the decrease of hemoglobin.The problem with the incomplete fill of the pump was resolved and the patient recovered.The blood pump pu valves; 25 ml in/out; ø 9 mm: lvad (sn (b)(6) and rvad (sn (b)(6) are still in use on the patient since (b)(6) 2024.
Additional Manufacturer Narrative
The excor blood pump pu valves; 25 ml in/out; ø 9 mm; lvad sn (b)(6) was in use on the patient from (b)(6) 2024 to date.The affected pump, sn (b)(6) remains on the patient and continues to be monitored.The event occurred on 2024-12-25, which is (12 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.The other pump rvad, sn 2021707 associated with this event will be submitted as 3004582654-202-00007.

• 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: 21212161
• Report Number: 3004582654-2025-00006
• Device Sequence Number: 19785867
• Product Code: DSQ
• UDI-Device Identifier: 04260090040119
• UDI-Public: (01)04260090040119(17)250430
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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): 01/22/2025

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: P25P-001X01
• 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: 12/26/2024
• Initial Report FDA Received Date: 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/16/2022
• 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: 5 YR
• Patient Sex: Female
• Patient Weight: 15 KG