MAUDE Adverse Event Report: BERLIN HEART GMBH EXCOR®; VENTRICULAR (ASSIST) BYPASS

Model Number	P10P-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ischemia Stroke (4418)
Date of Event	11/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On 2024-11-22 the site contacted berlin heart inc.(bhi) clinical affairs (ca) to report that the patient had brief episodes of left upper extremity (lue) and left lower extremity (lle) rhythmic movements lasting < 10 seconds on (b)(6) 2024.The next day ( (b)(6) 2024 ), the patient had similar episodes as well as a 15-20 seconds episode of bilateral upper extremely jerking as witness by primary team.Head ct scans without contrast revealed right frontal-parietal and left frontal and occipital hypodensities consistent with subacute infarcts.According to the site, the berlin heart excor blood pump pu valves; 10 ml in/out; ø 6 mm functioned as intended, with complete fill and ejection.Multiple deposits were noted in the pump.
Additional Manufacturer Narrative
The excor blood pumps pu valves; 10 ml in/out; ø 6 mm; sn (b)(6) was in use on the patient from (b)(6) 2024 to date.The affected pump, sn (b)(6) remains on the patient and continues to be monitored.The event occurred on 2024-11-05 , (22 days) after the pump was placed on the patient.We have reviewed the production records of the excor blood pump and the pump was produced according to our specification.

• Brand Name: EXCOR®
• Common Device Name: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): BERLIN HEART GMBH; wiesenweg 10; berlin, 12247 ; GM 12247
• MDR Report Key: 20896675
• Report Number: 3008454189-2024-00028
• Device Sequence Number: 9096979
• Product Code: DSQ
• UDI-Device Identifier: 04260090040102
• UDI-Public: (01)04260090040102(17)261031
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/10/2024
• Report Date (Section F): 12/10/2024

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 Model Number: P10P-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: 11/22/2024
• Device Age: 12 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/22/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/10/2024
• 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: 1 MO
• Patient Sex: Female
• Patient Weight: 4 KG
• Date Report Sent to FDA: 12/10/2024