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

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	02/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The excor blood pump, s/n, (b)(6) was on the patient since (b)(6) 2024 and remained on the patient.We have reviewed the production records of the excor blood pump, s/n (b)(6), this pump was produced according to our specification.
Event or Problem Description
Berlin heart was informed by the site on (b)(6) 2024 that a patient being supported with the excor pediatric vad system had developed hemolysis.The patient's ldh value increased to 1092, with an increased total bilirubin of 2.4md/dl.The upper limit of normal for ldh at this hospital is 409.The site is continuing to monitor hemolysis values.The pump functioned as intended with complete fill and ejection and remained on the patient.

• 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: 18842074
• Report Number: 3008454189-2024-00006
• Device Sequence Number: 7216092
• Product Code: DSQ
• UDI-Device Identifier: 04260090040126
• UDI-Public: 04260090040126
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 03/05/2024
• Report Date (Section F): 03/05/2024

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: 06/30/2024
• Device Model Number: P30P-001X01
• Device Catalogue Number: P30P-001X01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/26/2024
• Device Age: 19 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/26/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/05/2024
• 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: 13 KG
• Date Report Sent to FDA: 03/05/2024