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

Model Number	L20H-002X01
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The excor driving tube, lot 00140638, was in use on the patient for 113 days from (b)(6)2024 until the driving tube was exchanged on (b)(6)2025.The manufacturer has reviewed the production records of the excor driving tube, lot 00140638 and concluded that the product was produced according to their specifications.The excor® active driver was used on this patient.A detailed investigation report will be provided as soon as it is available.
Event or Problem Description
On (b)(6)2025 the clinic reported h1: pressure loss" alarm, insufficient air balancing valve openings, with no response in driving pressure triggered by the excor active driver.Berlin heart recommended a driver exchange.However, on (b)(6)2025., the site switched to a backup driver and replaced the driving tube without informing berlin heart clinical affairs and returned the previous driving tube to the manufacturer.Based on the log files of the new driver, no further h1 alarms were observed after replacing the driver and the driving tube.The patient remained stable, and no negative effects were reported.On (b)(6)2025, berlin heart received the used excor driving tube l20h-002x01 from the clinic.The returned driving tube is suspected to have an issue with leakage.
Additional Manufacturer Narrative
The excor driving tube, red; ø 6/8 mm l 2 m, lot 00140638, was in use on the patient from (b)(6) 2024 until it was replaced on (b)(6) 2025 for 113 days.We have reviewed the production records of the excor driving tube, lot 00140638 and concluded that the product was produced according to our specification.No damage was found during visual inspection of the returned driving tube.A detailed analysis of the driving tube was performed including a leakage test.No defect was found; the leakage test revealed no leaks in the driving tube.The excor active driving unit which was being used on the patient at the time of the incident, was also evaluated.The results revealed no pressure drop in the pneumatic system.Therefore, the possibility of any leakage could be ruled out.The suspected leakage could not be verified.No defect could be detected.The driving tube and the connected active driving unit met its specifications.

• 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: 21426602
• Report Number: 3004582654-2025-00010
• Device Sequence Number: 7855183
• Product Code: DSQ
• UDI-Device Identifier: 04260090040560
• UDI-Public: (01)04260090040560(17)270131(10)00140638
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2025

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: L20H-002X01
• Device Lot Number: 00140638
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2024
• 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 YR
• Patient Sex: Female
• Patient Weight: 20 KG