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

Model Number	P30P-001X01
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected blood pump pu valves; 30 ml in/out; ø 9 mm, sn (b)(6), was in use from 2025-04-28 until the pump was replaced on 2025-04-29.The event occurred on 2025-04-29, which is (1 day) after the pump in question 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 on the affected blood pump will be provided as soon as it is available.
Event or Problem Description
On 2025-04-29, the site contacted berlin heart inc.(bhi) clinical affairs (ca) to report that blood was observed between the blood membrane layers of the excor blood pump pu valves; 30 ml, in/out; ø 9 mm.The site reported that the patient remained hemodynamically stable during this time and the blood pump maintained full filling and ejection as intended.The site also reported that a visual irregularity of the membrane was apparent when assessing the pump from the air chamber side.Upon evaluation of the videos provided by the site, bhi ca recommended an immediate pump change.The blood pump was changed successfully without any complications.
Additional Manufacturer Narrative
The affected blood pump was in use on the patient for 1 day after the pump in question was replaced, and returned to berlin heart for investigation.Based on the videos provided by the clinic at the time of the event, the anomaly reported was confirmed.During initial visual inspection of the returned blood pump, slight reddish-brown discoloration could be detected between the membrane layers, indicating that blood had penetrated.The blood pump was then tested for functional performance.The pump performance met our specifications.The pump was completely filling and emptying.The membrane showed a visible irregularity.For further evaluation, the blood pump was disassembled, and individual membrane layers were individually tested.The blood-side membrane layer showed an imprint in the form of a punch-like damage.The damage corresponded in appearance to the shape and size of the de-airing needle tip and it was located directly opposite the de-airing port.Dried blood residues were found between the blood-side and the middle layer of the triple-layer membrane.The blood-side membrane layer was punctured, whereas the other two layers of the membrane are intact.The cause of the defect was most likely an accidental contact of the blood membrane with the de-airing needle when de-airing the blood pump during pump preparation.It resulted in damage of the blood-side layer of the membrane and blood accumulation in the membrane interstices between the blood-side and middle layer of the membrane.As a result, a visible irregularity in the membrane was detected when assessed from the air chamber.

• 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: 22013911
• Report Number: 3004582654-2025-00025
• Device Sequence Number: 12722144
• Product Code: DSQ
• UDI-Device Identifier: 04260090040126
• UDI-Public: (01)04260090040126(17)261231
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2025

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: P30P-001X01
• Device Lot Number: 2331002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2024
• 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: 4 YR
• Patient Sex: Male
• Patient Weight: 21 KG