MAUDE Adverse Event Report: BERLIN HEART GMBH BLOOD PUMP PU VALVES 60 ML, IN/OUT Ø12 MM; VENTRICULAR ASSIST DEVICE

Model Number	P60P-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemolysis (1886)
Date of Event	07/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Berlin heart was informed on (b)(6) 2023 that the patient in excor system developed hemolysis.On (b)(6) 2023, the patient's ldh values increased to 3900, and haptoglobin <7 mg/dl.In the echocardiography of the outflow cannula on the ascending aorta appeared narrow, with a mean pressure gradient of 70mmhg.This finding indicates stenosis and could be the reason for the elevated hemolysis and relatively high systolic driving pressure of the lvad.
Additional Manufacturer Narrative
The excor blood pump, s/n, (b)(6) on the patient at the time of the event was in use since (b)(6) 2023 until (b)(6) 2023 (7 days).We have reviewed the production records of the excor blood pump.This pump was produced according to our specification.

• Brand Name: BLOOD PUMP PU VALVES 60 ML, IN/OUT Ø12 MM
• Common Device Name: VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): BERLIN HEART GMBH; wiesenweg 10; berlin, deu 12247 ; GM 12247
• Manufacturer (Section G): BERLIN HEART GMBH; wiesenweg 10; berlin, deu 12247 ; GM 12247
• Manufacturer Contact: dudley rajapaksa ; 9391 grogans mill road; suite a6; the woodlands, TX 77380 ; 2818639706
• MDR Report Key: 17354099
• Report Number: 3004582654-2023-00025
• Device Sequence Number: 14718940
• Product Code: DSQ
• UDI-Device Identifier: 04260090040027
• UDI-Public: 04260090040027
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/19/2023

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: 01/31/2026
• Device Model Number: P60P-001
• Device Catalogue Number: P60P-001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 07/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2023
• 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: 16 YR
• Patient Sex: Male
• Patient Weight: 60 KG