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

Model Number	P25P-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhagic Stroke (4417)
Date of Event	10/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The rvad excor blood pump pu valves; 25 ml in/out; ø 9 mm; sn (b)(6) was in use on the patient from (b)(6) 2025 until the patient was escalated to continuous flow (right side only) on (b)(6) 2025.The event occurred on 2025-10-05, which is 6 days after the patient was escalated to continuous flow.We have reviewed the production records of the rvad excor blood pump and concluded the pump was produced according to our specification.
Event or Problem Description
The site contacted berlin heart inc (bhi) clinical affairs (ca) on (b)(6) 2025 to report that the patient who was previously supported in a bvad configuration had been escalated on (b)(6) 2025 to continuous flow circuit on the right side.On (b)(6) 2025, the overall condition of the patient had worsened and therefore the patient was sedated and chemically paralyzed for hemodynamic instability.On (b)(6) 2025, the team noted pupillary changes followed by possible seizure activity and posturing, prompting a ct scan.Imaging revealed extensive intraventricular hemorrhage and a new large right parietal intraparenchymal hemorrhage.An eeg performed from (b)(6) 2025 demonstrated a severely suppressed background, consistent with severe diffuse neuronal dysfunction and encephalopathy.Neurosurgical consultation determined the findings were catastrophic and irreversible, and no surgical intervention was offered.Neurology was consulted for seizure management and medical stabilization.Due to poor neurological prognosis, the patient was withdrawn from care upon request by the patient's famliy and was expired on (b)(6) 2025.
Additional Manufacturer Narrative
Incorrect code for investigation findings has been entered inadvertently in the initial report.Therefore, it has been corrected from 3233 to 3221 in section h6.

• 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: 23468402
• Report Number: 3004582654-2025-00062
• Device Sequence Number: 12995678
• Product Code: DSQ
• UDI-Device Identifier: 04260090040119
• UDI-Public: (01)04260090040119(17)270426
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2025

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: P25P-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/28/2024
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 24 MO
• Patient Sex: Female
• Patient Weight: 11 KG