MAUDE Adverse Event Report: BERLIN HEART GMBH BLOOD PUMP PU VALVES 15 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	Ischemia Stroke (4418)
Date of Event	10/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The excor blood pump, s/n, (b)(6) on the patient was in use from (b)(6) 2023 until the time of the incident on (b)(6) 2023 (116 days).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 inc.Was informed by the clinic that a patient developed lue weakness.No acute interventions but recommendation from neurology team was to decrease ptt goal, hold asa, maintain normothermia, normotension, normoglycemia.The patient previously noted to have stable pinpoint thrombin deposits in rvad pump.

• Brand Name: BLOOD PUMP PU VALVES 15 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: 18095183
• Report Number: 3008454189-2023-00016
• Device Sequence Number: 20514609
• Product Code: DSQ
• UDI-Device Identifier: 04260090040119
• UDI-Public: 04260090040119
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/08/2023
• Report Date (Section F): 11/08/2023

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: 11/30/2025
• Device Model Number: P25P-001
• Device Catalogue Number: P25P-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/26/2023
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/26/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/08/2023
• 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: 15 MO
• Patient Sex: Male
• Patient Weight: 11 KG
• Date Report Sent to FDA: 11/08/2023