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

Model Number	P25P-001X01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemolysis (1886)
Date of Event	01/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The site contacted berlin heart inc.(bhi) clinical affairs (ca) on (b)(6) 2025 to report that the patient being supported with an excor pediatric vad system had elevated ldh levels.The patient's ldh value showed from 688 u/l to 1523 u/l and plasma free hemoglobin increased from 3.0 mg/dl to 9.9 mg/dl on (b)(6) 2025.Both values are 2.5 times higher than upper limits of normal.The site further reported an increase in total bilirubin to 6.4 mg/dl from baseline of 1.7 mg/dl.The site also stated that the increase in the abnormal lab values was considered to be multifactorial.According to the site, the excor blood pump pu valves; 25 ml in/out; ø 9 mm; sn (b)(6) functioned as intended with complete filling and ejection.There were no deposits, or any abnormal sounds noted in the excor blood pump.
Additional Manufacturer Narrative
The excor blood pump pu valves; 25 ml in/out; ø 9 mm; sn (b)(6) was in use on the patient from (b)(6) 2024 to date.The event occurred on 2025-01-26, which is (45 days) after the pump was placed on the patient.As of (b)(6) 2025, the site continues to monitor the pump and does intend to change the pump unless the patient begins to experience hematuria.We have reviewed the production records of the excor blood pump sn (b)(6) and the pump was produced according to our specification.

• Brand Name: EXCOR®
• Common Device Name: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): BERLIN HEART GMBH; wiesenweg 10; berlin, 12247 ; GM 12247
• MDR Report Key: 21462415
• Report Number: 3008454189-2025-00004
• Device Sequence Number: 7764169
• Product Code: DSQ
• UDI-Device Identifier: 04260090040119
• UDI-Public: (01)04260090040119(17)260930
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/25/2025
• Report Date (Section F): 02/25/2025

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 Expiration Date: 09/30/2026
• Device Model Number: P25P-001X01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/27/2025
• Device Age: 15 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/27/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/25/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 8 YR
• Patient Sex: Female
• Patient Weight: 14 KG
• Date Report Sent to FDA: 02/25/2025