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

Model Number	P10P-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemolysis (1886)
Date of Event	01/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The initial report 3004582654-2025-00012 was originally submitted on 2025-02-25.However, the acknowledgment 3 was not received.Therefore, this report is being re-submitted based on an email from fda dated 2025-03-18.The excor blood pump pu valves; 10 ml in/out; ø 6 mm; sn (b)(6) was in use on the patient from (b)(6) 2025 to date.The event occurred on (b)(6) 2025, which is (14 days) after the pump was placed on the patient.We have reviewed the production records of the excor blood pump and 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 being supported with an excor pediatric vad system continued to have hemolysis since the implant on (b)(6) 2025.The ldh value showed >1000 u/l, which is 2.5 times higher than upper limits of normal and plasma free hemoglobin value was also noted to be 2.5 times higher than upper limits of normal.According to the site, the excor blood pump pu valves; 10 ml in/out; ø 6 mm; sn (b)(6) performed as intended with complete fill and ejection.There were no abnormal sounds from 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: 21682369
• Report Number: 3004582654-2025-00012
• Device Sequence Number: 8210209
• Product Code: DSQ
• UDI-Device Identifier: 04260090040102
• UDI-Public: (01)04260090040102(17)270921
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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 Practitioner
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 03/24/2025

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: P10P-001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2024
• 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: Other
• Patient Age: 2 MO
• Patient Sex: Male
• Patient Weight: 5 KG