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
Additional Manufacturer Narrative
The excor blood pump pu valves; 25 ml in/out; ø 9 mm; sn 2330573 was in use on the patient from (b)(6) 2024 to date.The event occurred on (b)(6) 2025, 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.
Event or Problem Description
The site contacted berlin heart inc.(bhi) clinical affairs (ca) on 2025-01-27 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.

• 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: 21462296
• Report Number: 3004582654-2025-00011
• Device Sequence Number: 8189334
• 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
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/08/2023
• 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: 8 YR
• Patient Sex: Female
• Patient Weight: 14 KG