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

Model Number	P10P-001
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	Hemolysis (1886)
Date of Event	12/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The excor blood pump pu valves; 10 ml in/out; ø 6 mm, s/n (b)(6), was in use on the patient from (b)(6) 2025 until the pump was exchanged on (b)(6) 2025 (27 days).We have reviewed the production records of the excor blood pump, s/n (b)(6).This pump was produced according to our specification.
Event or Problem Description
Berlin heart clinical affairs was informed by the clinic about a noisy excor blood pump.The excor blood pump was exchanged on (b)(6) 2025.The patient's health deteriorated at the time of the event.The next day, the patient was stable.The blood pump maintained complete filling and ejection throughout.Further on the clinic informed that the patient showed signs of hemolysis with observed ldh valves of 1131 u/l, and that the patient has been transfused for the third time.Berlin heart was notified by the clinic, that the hemolysis values went back to normal after the exchange 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: 24005642
• Report Number: 3004582654-2026-00001
• Device Sequence Number: 17329981
• Product Code: DSQ
• UDI-Device Identifier: 04260090040102
• UDI-Public: (01)04260090040102(17)280324
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Replace
• Type of Report: Initial
• Report Date (Section B): 01/08/2026

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: P10P-001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/16/2025
• 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: 3 MO
• Patient Sex: Female