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

Model Number	P15P-001
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected excor blood pump pu valves; 15 ml in/out; ø 9 mm, sn (b)(6) was in use since (b)(6) 2024 to date.The event occurred on (b)(6) 2025, which is (110 days) after the pump in question was placed on the patient.We have reviewed the production records of the excor blood pump, and determined that it was produced according to our specification.The excor® ikus stationary driving unit is used on this patient.
Event or Problem Description
On (b)(6) 2025 berlin heart gmbh clinical affairs (ca) was informed by the korean distributor that during intervention of removing fibrin in the connector set, it was noted that an air leakage occurred at the area of the blood pump connector to the driving tube.Upon evaluation of the pictures and videos provided, ca recommended replacing the blood pump and requested that the blood pump along with the driving tube be returned to berlin heart for investigation.There were no abnormalities noted in the movement of the blood pump and no damage to the connector was observed.Therefore, the clinic decided to retain them and monitor the patient.As of (b)(6) 2025, the patient remains clinically stable and no negative effects were noted due to the incident.

• 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: 21667501
• Report Number: 3004582654-2025-00018
• Device Sequence Number: 8228456
• Product Code: DSQ
• UDI-Device Identifier: 04260090040157
• UDI-Public: (01)04260090040157(17)261130
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 03/21/2025

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: P15P-001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2024
• 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: 15 MO
• Patient Sex: Female
• Patient Weight: 5 KG