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

Model Number	P30P-001X01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemolysis (1886)
Date of Event	09/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The site contacted berlin heart inc.(bhi) clinical affairs (ca) to report that the patient supported with an excor blood pump in bi-vad configuration developed hemolysis.The patient's ldh value increased to 2511u/l, whereas the ldh value indicated 937 u/l before implantation.The patient was initially supported with excor active driver then transitioned to an ikus driver due to an increase in hemolysis.According to the site, the excor blood pumps pu valves; 30 ml in/out; ø 9 mm; rvad sn (b)(6) and lvad, sn (b)(6) performed as intended for clinical condition with full fill and ejection.There were no deposits noted in the excor blood pumps.On (b)(6) 2024 bhi ca was informed that the patient was escalated to centrimag due to continued hemolysis.
Additional Manufacturer Narrative
The excor blood pumps pu valves; 30 ml in/out; ø 9 mm; rvad, sn (b)(6) was in use on the patient from (b)(6) 2024 until the centrimag was escalated on (b)(6) 2024 for 3 days.The excor® active driving unit initially used on this patient is under clinical study ide# (b)(6).We have reviewed the production records of the excor blood pump rvad, sn (b)(6) and the pump was produced according to our specification.The other pump lvad, sn (b)(6) associated with this event is submitted as 3004582654-2024-00044.

• 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: dudley rajapaksa ; 9391 grogan's mill road; suite a-6; the woodlands, TX 77380 ; 2818639706
• MDR Report Key: 20317490
• Report Number: 3004582654-2024-00045
• Device Sequence Number: 7630433
• Product Code: DSQ
• UDI-Device Identifier: 04260090040126
• UDI-Public: (01)04260090040126(17)261231
• 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: 2024
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 09/26/2024

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: P30P-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: 09/11/2024
• Initial Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/13/2024
• 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: 7 YR
• Patient Sex: Female
• Patient Weight: 25 KG