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

Model Number	P50P-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Brain Injury (2219)
Date of Event	01/06/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The excor blood pump pu valves; 50 ml in/out; ø 12 mm, lvad, s/n: (b)(6) and rvad, s/n: (b)(6), are used on the patient from on (b)(6) 2026 until the pumps were removed from the patient on (b)(6) 2026.The event occurred on 2026-01-06, which is (5 days) after the pumps were placed on the patient.The patient was being supported with an excor ikus driving unit.We have reviewed the production records of the excor blood pumps.The pumps were produced according to our specifications.The excor rvad blood pump s/n: (b)(6) information is as follows: the model number for this lot: p50p-001.The manufacture date for this lot: 2025-08-12.The expiration date for this lot: 2028-07-19.Udi: ((b)(4).
Event or Problem Description
The site contacted berlin heart clinical affairs (ca) on 2026-01-12 to report that the patient presented on (b)(6) 2026 with an acute change to neurologic exam with bilateral fixed and dilated pupils with npi is 0.Two head ct were performed showing diffuse loss of gray-white matter differentiation through the bilateral cerebral and cerebellar hemispheres, slightly more conspicuous compared to prior exam.Redemonstration of diffuse effacement of the extra-axial spaces and basal cisterns.New mild cerebellar tonsillar herniation.The ventricles are slit like, slightly decreased compared to prior study.There is no significant midline shift.There is no mass or intracranial hemorrhage.The osseous structures appear normal.Scattered paranasal sinus opacification predominantly in the sphenoid and ethmoid sinuses.Opacification of bilateral mastoid air cells and middle ear cleft, left greater than right.The patient continued to be monitored, and the patient was normothermic, normotensive, without paralysis/sedation and without significant metabolic derangements at that time.On (b)(6) 2026 the patient was withdrawn from support and expired due to poor outcome prognosis.The patient was being supported with the excor system in bi-vad configuration.The berlin excor blood pump functioned as intended maintaining full fill and eject.No deposits were noted in both the pumps at the time of the event.

• 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: 24296471
• Report Number: 3004582654-2026-00007
• Device Sequence Number: 15811508
• Product Code: DSQ
• UDI-Device Identifier: 04260090040010
• UDI-Public: (01)04260090040010(17)270729
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P160035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 02/09/2026

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: P50P-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: 01/12/2026
• Initial Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/23/2024
• 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: 5 YR
• Patient Sex: Male
• Patient Weight: 32 KG