MAUDE Adverse Event Report: BERLIN HEART GMBH BLOOD PUMP PU VALVES 25 ML, IN/OUT Ø9 MM; VENTRICULAR ASSIST DEVICE

Model Number	P25P-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemolysis (1886)
Date of Event	02/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Berlin heart gmbh was informed by the distributor that a patient being supported with the excor pediatric vad system had developed hemolysis.The patient was switched from the excor blood pump to a centrifugal pump on 2024-02-13.The patient continues to use the excor cannula.According to the updated information form 2024-02-19, the patient was stable with decreasing hemolysis.
Additional Manufacturer Narrative
The excor blood pump, s/n, (b)(6) was in use on the patient from 2024-01-10 until the removal of the excor pump on 2024-02-13 for 34 days.We have reviewed the production records of the excor blood pump, s/n (b)(6), this pump was produced according to our specification.

• Brand Name: BLOOD PUMP PU VALVES 25 ML, IN/OUT Ø9 MM
• Common Device Name: VENTRICULAR ASSIST DEVICE
• 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: 18880806
• Report Number: 3004582654-2024-00017
• Device Sequence Number: 12734198
• Product Code: DSQ
• UDI-Device Identifier: 04260090040119
• UDI-Public: 04260090040119
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/11/2024

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 Expiration Date: 10/31/2025
• Device Model Number: P25P-001
• Device Catalogue Number: P25P-001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2024
• Initial Report FDA Received Date: 03/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2022
• 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: 10 MO
• Patient Sex: Female
• Patient Weight: 7 KG