MAUDE Adverse Event Report: BERLIN HEART GMBH BLOOD PUMP PU VALVES 30 ML, IN/OUT Ø9 MM; VENTRICULAR ASSIST DEVICE

Model Number	P30P-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemolysis (1886)
Date of Event	02/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The site notified berlin heart inc.Clinical affairs that a pump change had occurred on a patient being supported with the excor pediatric vad system due to an audible "crunching" noise.Additional information provided by the site, on 03-01-2024, reported that the patient was exhibited ldh lab values consistent with hemolysis.The patient's ldh level increased from 508 on 2024-02-13 to 1200 on 2024-02-25.According to the site, the blood pump maintained complete filling and ejection throughout.
Additional Manufacturer Narrative
The excor blood pump, s/n (b)(6) on the patient since 2024-02-09 until the time of the event on 2024-02-25 (16 days) we have reviewed the production records of the excor blood pump s/n (b)(6).This pump was produced according to our specification.A detailed investigation report will be provided as soon as it is available.

• Brand Name: BLOOD PUMP PU VALVES 30 ML, IN/OUT Ø9 MM
• Common Device Name: VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): BERLIN HEART GMBH; wiesenweg 10; berlin, 12247 ; GM 12247
• MDR Report Key: 18881560
• Report Number: 3008454189-2024-00007
• Device Sequence Number: 9135417
• Product Code: DSQ
• UDI-Device Identifier: 04260090040126
• UDI-Public: 04260090040126
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/11/2024
• Report Date (Section F): 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: 08/31/2026
• Device Model Number: P30P-001
• Device Catalogue Number: P30P-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/25/2024
• Device Age: 17 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/25/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/11/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 24 MO
• Patient Sex: Male
• Patient Weight: 10 KG
• Date Report Sent to FDA: 03/11/2024