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

Model Number	P15P-001
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Berlin heart gmbh clinical affairs (ca) was informed by the italian distributor on 2025-03-23 that a pump change was performed due to a suspicious membrane issue on the patient being supported with an excor pediatric vad system.The site changed the pump without complications and reported that the patient remained hemodynamically stable throughout.The patient had no negative effects due to the incident.Therefore, initially berlin heart has determined this event as not reportable.However upon reviewing the failure investigation on 2025-09-17, the event was determined as reportable due to a confirmed defect in one of the layers of the triple layer membrane.
Additional Manufacturer Narrative
The affected blood pump pu valves; 15 ml in/out; ø 9 mm, sn (b)(6), was in use from (b)(6) 2024 until the pump was replaced on (b)(6) 2025.The event occurred on 2025-03-22, which is 194 days after the pump in question was placed on the patient.On the same day as the event, the affected pump was replaced and sent to berlin heart for investigation.During the visual inspection of the returned blood pump, a pillow-like structure was detected.The blood pump was tested for functionality.The pump performance was approximately 40% and the blood pump did not fill and empty completely.For internal evaluation, the blood pump was opened and the individual membrane layers were examined.A leak was detected in the air-side area of the triple-layer membrane.The leakage was located along the rolling radius of the stabilization ring, and graphite agglomerates were observed between the membranes.The blood side and the middle layer of the membrane remained intact.The membrane thickness of the defective air-side layer and the adjacent layer were measured.The membrane thickness met the specifications at all measuring points and in the area of the leak.Based on the evaluation, the cause of the failure is most likely abrasion between the membranes.The resulting graphite agglomerates led to increased friction between the membrane layers at certain points, which ultimately led to the defect in the air-side layer of the triple-layer membrane.The defect caused a formation of air pockets between the membranes, which resulted in a reduced delivery volume (incomplete filling and emptying) of the blood pump.

• 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: mary beth tate ; 9391 grogan's mill road; suite a-6; the woodlands, TX 77380 ; 7347092080
• MDR Report Key: 23327065
• Report Number: 3004582654-2025-00056
• Device Sequence Number: 10572866
• Product Code: DSQ
• UDI-Device Identifier: 04260090040157
• UDI-Public: (01)04260090040157(17)250831
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 10/17/2025

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 Expiration Date: 08/31/2025
• Device Model Number: P15P-001
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2025
• Initial Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2022
• 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
• Patient Age: 5 YR
• Patient Sex: Female
• Patient Weight: 14 KG